Last update October 1, 2020
New Off-Label Uses
| Monograph | Off-Label Use Proposed | Date | Participating Panel Member(s) | Strength of Recommendation | Level of Evidence | Off-Label Use Vote Record | Panel Member Conflict of Interest Statement |
|---|---|---|---|---|---|---|---|
| Goserelin | Prevention of early menopause during chemotherapy for early stage hormone receptor negative breast cancer | 2015.03 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the Off-Label Use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cisplatin | Breast cancer (triple-negative) | 2015.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | B | For the Off-Label Use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cisplatin | Penile cancer | 2015.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Nick Link, PharmD, BCOP Mark Holdsworth, PharmD |
Equivocal | B | For the Off-Label Use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Idarubicin | AML (Pediatric), relapsed/refractory | 2015.04 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Mark Holdsworth, PharmD Heidi Trinkman, PharmD Polly Kintzel, PharmD, BCOP, BCPS |
Strong (for off-label use) | A | For the Off-Label Use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Idarubicin | AML (Pediatric), newly diagnosed | 2015.04 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Mark Holdsworth, PharmD Heidi Trinkman, PharmD Polly Kintzel, PharmD, BCOP, BCPS |
Equivocal | B | For the Off-Label Use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Topotecan | Primary CNS lymphoma, relapsed/refractory | 2015.06 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | C | For the Off-Label Use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nivolumab | Melanoma, unresectable or metastatic (without BRAF mutation), first-line, single-agent therapy | 2015.07 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Palbociclib | Breast cancer, advanced (second-line endocrine-based therapy) | 2015.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link. PharmD, BCOP |
Strong | A | For the Off-Label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Fulvestrant | Breast cancer, advanced (second-line endocrine-based combination therapy) | 2015.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link. PharmD, BCOP |
Strong | A | For the Off-Label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cabozantinib | Renal cell cancer, clear cell (advanced) | 2015.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the Off-Label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nivolumab | Renal cell cancer, clear cell (advanced) | 2015.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest Conflict of interest No conflict of interest No conflict of interest |
| Goserelin | Breast cancer, advanced (second-line endocrine-based combination therapy [with palbociclib and fulvestrant] in pre- or peri-menopausal women) | 2015.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link. PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ipilimumab | Melanoma, unresectable or metastatic, first-line combination therapy | 2015.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link. PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Trabectedin | Ovarian cancer, refractory (platinum-sensitive) | 2016.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Docetaxel | Prostate cancer, metastatic, hormone-sensitive | 2016.03 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Defibrotide | Hepatic sinusoidal obstruction syndrome, prevention (pediatrics) | 2016.04 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Heidi Trinkman, PharmD Mark Holdsworth, PharmD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Vemurafenib | Erdheim-Chester disease, refractory (with BRAF V600E mutation) | 2016.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Vemurafenib | Non-small cell lung cancer, refractory (with BRAF V600 mutation) | 2016.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nivolumab | Head and neck cancer, squamous cell (recurrent or metastatic) | 2016.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Axitinib | Thyroid cancer (advanced, differentiated) | 2016.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Mark Holdsworth, PharmD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Carfilzomib | Waldenström macroglobulinemia | 2016.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Regorafenib | Hepatocellular cancer (intermediate or advanced) | 2016.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Mark Holdsworth, PharmD Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pembrolizumab | Merkel cell carcinoma (advanced) | 2016.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Dabrafenib | Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V660E mutation) | 2016.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Trametinib | Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V660E mutation) | 2016.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nivolumab | Small cell lung cancer (progressive) | 2016.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Mitomycin | Vulvar cancer, advanced | 2016.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Carboplatin | Anal cancer | 2016.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Carboplatin | Gastric cancer | 2016.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Carboplatin | Thyroid Cancer | 2016.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Carboplatin | Wilms Tumor | 2016.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Mark Holdsworth, PharmD Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Fluorouracil | Vulvar cancer, advanced | 2016.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Malignant pleural mesothelioma (unresectable) | 2016.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Hereditary hemorrhagic telangiectasia | 2016.12 (updated 2020.04) |
Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Nick Link, PharmD, BCOP Heidi Trinkman, PharmD |
Equivocal | C, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Temsirolimus | Endometrial cancer (locally advanced, recurrent and/or metastatic) | 2017.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pembrolizumab | Urothelial carcinoma (advanced) | 2017.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Sargramostim | Neuroblastoma, high-risk (pediatrics) | 2017.03 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Heidi Trinkman, PharmD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Isotretinoin | Neuroblastoma, high-risk (pediatrics) | 2017.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly KIntzel, PharmD, BCOP, BCPS Heidi Trinkman, PharmD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ipilimumab | Small cell lung cancer (progressive) | 2017.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Tocilizumab | Cytokine release syndrome (due to BiTE therapy), severe or life-threatening | 2017.04 (modified 2017.09) | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Heidi Trinkman, PharmD Omer Koc, MD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Capecitabine | Pancreatic cancer (adjuvant therapy) | 2017.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Gemcitabine | Pancreatic cancer (adjuvant therapy) | 2017.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Capecitabine | Anal carcinoma | 2017.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Antithymocyte globulin (rabbit;Thymoglobulin) | Chronic graft-versus-host disease (prevention) | 2017.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Olaparib | Breast cancer, metastatic, HER2-negative, BRCA-mutated | 2017.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Abiraterone | Prostate cancer, metastatic or high-risk locally advanced, castration-sensitive | 2017.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Rituximab | Myasthenia gravis (refractory) | 2017.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Heidi Trinkman, PharmD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Rituximab | Neuromyelitis optica (relapse prevention) | 2017.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Rituximab | Pemphigus vulgaris (newly diagnosed) | 2017.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Heidi Trinkman, PharmD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Capecitabine | Breast cancer (adjuvant therapy) | 2017.07 (updated 2019.03) | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Capecitabine | Hepatobiliary cancer (adjuvant therapy) | 2017.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Gliomas (recurrent or progressive (pediatrics) | 2017.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Omer Koc, MD Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Medulloblastoma (relapsed or refractory) | 2017.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Nick Link, PharmD, BCOP Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Solid tumors, refractory (pediatrics) | 2017.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Corey Carter, MD Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Lenvatinib | Hepatocellular carcinoma (advanced) | 2017.11 (updated; see 2018.03) | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Durvalumab | Non-small cell lung cancer (unresectable, locally advanced) | 2017.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Fluorouracil | Glaucoma surgery (adjunctive therapy) | 2017.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Alemtuzumab | Aplastic anemia, refractory | 2017.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Mark Holdsworth, PharmD Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Alemtuzumab | Hemophagocytic lymphohistiocytosis, refractory | 2017.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Mark Holdsworth, PharmD Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Irinotecan (conventional) | Small cell lung cancer (limited stage) | 2017.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Corey Carter, MD Nick Link, PharmD, BCOP |
Equivocal | B, G | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Diabetic macular edema | 2017.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Irinotecan (conventional) | Unknown primary adenocarcinoma | 2017.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, Pharm D, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Tamoxifen | Mastalgia, severe | 2017.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Oxaliplatin | Neuroblastoma, high-risk, relapsed/refractory (pediatrics) | 2017.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Nick Link, PharmD, BCOP Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cladribine | T-cell large granular lymphocytic leukemia (refractory) | 2017.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Alemtuzumab | Mycosis fungoides/Sezary syndrome (advanced) | 2018.01 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Alemtuzumab | T-cell large granular lymphocytic leukemia | 2018.01 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nilotinib | Acute lymphoblastic leukemia, Ph+ | 2018.01 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Heidi Trinkman, PharmD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Streptozocin | Gastrointestinal neuroendocrine tumors | 2018.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Trastuzumab | Breast cancer, metastatic, HER2-positive, hormone receptor-positive (in combination with an aromatase inhibitor) | 2018.03 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Lenvatinib | Hepatocellular carcinoma (advanced) | 2018.03 (updated from 2017.11) | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the updated LOE /Strength of Recommendation: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ruxolitinib | Graft versus host disease (acute or chronic; treatment) | 2018.04 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Heidi Trinkman, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Filgrastim | Alcoholic hepatitis (severe) | 2018.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Prednisone | Multiple myeloma (previously untreated; transplant ineligible) | 2018.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Everolimus | Hodgkin lymphoma (relapsed or refractory) | 2018.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Everolimus | Thymoma and thymic carcinomas (advanced, refractory) | 2018.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cetuximab | Penile cancer (squamous cell, advanced or metastatic) | 2018.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Methylprednisolone | Prostate cancer (metastatic, castration-resistant) | 2018.07 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Dolasetron | Chemotherapy-associated nausea and vomiting (high emetic potential) (adults) | 2018.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Strong | G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Dolasetron | Chemotherapy-associated nausea and vomiting (low emetic potential) (adults) | 2018.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Strong | G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ondansetron | Carcinoid syndrome-associated diarrhea (severe, refractory; alternative agent) | 2018.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nivolumab | Melanoma, metastatic with brain metastases | 2018.09 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP Elizabeth Connor, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ipilimumab | Melanoma, metastatic with brain metastases | 2018.09 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP Elizabeth Connor, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Paclitaxel (protein bound) | Bladder cancer, metastatic, platinum-resistant | 2018.09 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Paclitaxel (protein bound) | Cervical cancer, advanced, recurrent or persistent | 2018.09 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Atezolizumab | SCLC (extensive stage; first-line therapy) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Brigatinib | Non-small cell lung cancer, advanced, (initial ALK-inhibitor therapy) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ramucirumab | Hepatocellular carcinoma (advanced, relapsed/refractory) | 2018.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pembrolizumab | Melanoma, stage III (adjuvant treatment) | 2018.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Temozolomide | Pediatric CNS tumors (anaplastic astrocytoma, brain stem glioma or medulloblastoma), relapsed or refractory | 2018.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Jennifer Thackray, PharmD, BCPPS, BCPS Heidi Trinkman, PharmD Mark Holdsworth, PharmD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Procarbazine | CNS tumors, low grade gliomas (in children) | 2018.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Heidi Trinkman, PharmD Jennifer Thackray, PharmD, BCPPS, BCPS Mark Holdsworth, PharmD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Vincristine | Hepatoblastoma | 2018.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Heidi Trinkman, PharmD Jennifer Thackray, PharmD, BCPPS, BCPS Mark Holdsworth, PharmD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Doxorubicin (conventional) | Hepatoblastoma (pediatrics) | 2018.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Jennifer Thackray, PharmD, BCPPS, BCPS Heidi Trinkman, PharmD Mark Holdsworth, PharmD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cabozantinib | Hepatocellular carcinoma (advanced) | 2018.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Carfilzomib | Multiple myeloma (newly diagnosed) | 2019.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Trastuzumab | Endometrial cancer (uterine serous), advanced or recurrent, HER2-positive | 2019.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ado-trastuzumab emtansine | Breast cancer, early, HER2-positive (adjuvant therapy for residual disease) | 2019.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Zoledronic acid | Breast cancer, early stage, adjuvant therapy in postmenopausal females | 2019.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B,G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Oxaliplatin | Pancreatic cancer, potentially curable (adjuvant therapy) | 2019.05 (updated 2019.07) |
Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Leucovorin calcium | Pancreatic cancer, potentially curable (adjuvant therapy) | 2019.05 (updated 2019.07) |
Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Irinotecan | Pancreatic cancer, potentially curable (adjuvant therapy) | 2019.05 (updated 2019.07) |
Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Strong | A, G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ibandronate | Prostate cancer, metastatic, bone pain (alternative agent) | 2019.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, Pharm D Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Vincristine | Merkel cell carcinoma | 2019.05 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Venetoclax | Mantle cell lymphoma, relapsed/refractory | 2019.06 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Capecitabine | Head and neck cancer, squamous cell (recurrent or metastatic; palliative treatment) | 2019.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Mitomycin | Hepatocellular carcinoma (chemoembolization) | 2019.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Olaparib | Pancreatic cancer, metastatic, BRCA-mutated (maintenance therapy) | 2019.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Vinblastine | Kaposi sarcoma, oral lesions (intralesional) | 2019.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Mark Holdsworth, PharmD Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Encorafenib | Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) | 2019.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Binimetinib | Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) | 2019.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Cetuximab | Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) | 2019.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ziv-aflibercept | Ascites (malignant; due to malignant ovarian cancer) | 2019.08 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Elizabeth Connor, MD |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Chlorambucil | Necrobiotic xanthogranuloma | 2019.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Chlorambucil | Idiopathic membranous nephropathy | 2019.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Angela German, PharmD, BCOP Mark Holdsworth, PharmD |
Equivocal | B,G | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pentostatin | T-cell large granular lymphocytic leukemia | 2019.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Mesna | Prevention of cyclophosphamide-induced hemorrhagic cystitis in patients with rheumatic or autoimmune disorders | 2019.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Etoposide | Hemophagocytic lymphohistiocytosis | 2019.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Angela German, PharmD, BCOP Jordan Lundberg, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pazopanib | Desmoid tumors (progressive) | 2019.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Luspatercept | Anemia due to lower-risk myelodysplastic syndromes with ring sideroblasts | 2020.01 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Angela German, Pharm D, BCOP Jordan Lundberg, PharmD, BCOP |
Strong | A | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Lenalidomide | Smoldering myeloma (high-risk) | 2020.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, Pharm D, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Regorafenib | Osteosarcoma, metastatic, progressive (recurrent, relapsed, or refractory) | 2020.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jennifer Thackray, PharmD, BCPPS, BCPS |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pembrolizumab | Breast cancer (triple negative, early stage) | 2020.03 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Elizabeth Connor, MD |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pembrolizumab | Mycosis fungoides, Sézary syndrome (relapsed/refractory) | 2020.03 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP Nick Link, PharmD, BCOP Angela German, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Interferon alfa-2b | Essential thrombocythemia (advanced) | 2020.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Interferon alfa-2b | Myelofibrosis (early) | 2020.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Mark Holdsworth, PharmD Nick Link, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Interferon alfa-2b | Polycythemia vera (advanced) | 2020.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Daratumumab | Systemic light chain amyloidosis (relapsed) | 2020.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Pembrolizumab | Malignant pleural mesothelioma, relapsed/refractory, PD-L1 positive | 2020.05 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Omer Koc, MD |
Equivocal | C | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Porfimer | Cholangiocarcinoma (unresectable) | 2020.06 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Fam-trastuzumab deruxtecan | Gastric cancer, advanced, previously treated (HER2-positive) | 2020.07 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Paclitaxel (conventional) | Anal cancer (advanced) | 2020.08 |
Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Omer Koc, MD Jordan Lundberg, PharmD, BCOP |
Equivocal | B | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Avelumab | Gestational trophoblastic neoplasia, resistant | 2020.09 |
Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Equivocal | C | For the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
Off-Label Uses Removed From Database
| Monograph | Off-Label Use Removed | Date | Participating Panel Member(s) | Strength of Recommendation | Off-Label Use Removal Vote Record | Conflict of Interest Statement |
|---|---|---|---|---|---|---|
| Ixabepilone | Endometrial cancer (second-line treatment) | 2014.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Mark Holdsworth, PharmD |
Against off-label use: Evidence suggests a lack of support for this off-label use; additional studies are needed to further define the role of ixabepilone in the management of this condition | Remove the Off-Label Use: 4 of 5 (add to unsupported use) | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Bevacizumab | Ovarian cancer, advanced, recurrent (platinum sensitive) | 2014.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA-approved (no panel vote needed - removed from off-label uses due to approval by FDA) | N/A | N/A |
| Alemtuzumab | Multiple sclerosis | 2014.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA-approved (no panel vote needed - removed from off-label uses due to approval by FDA) | N/A | N/A |
| Medroxyprogesterone injection | Renal Carcinoma (labeled use, add to Use: Unsupported) | 2015.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Cater, MD Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS |
Against Off-Label Use | Add to Use: Unsupported: 5 of 5 (add to unsupported use) | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Decitabine | Sickle Cell Anemia | 2015.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Heidi Trinkman, PharmD |
Against off-label use: Evidence suggests a lack of support for this off-label use; evidence-based guidelines do not mention decitabine as a therapeutic option for management of sickle cell anemia. Additional studies are needed to further define the role of decitabine in the management of this condition. | Remove the Off-Label Use: 4 of 5 (add to unsupported use) | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Topotecan | Merkel cell carcinoma | 2015.06 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Against off-label use: Limited evidence exists for the use of topotecan in the management of merkel cell carcinoma; additional trials are needed to further define the role of topotecan in the treatment of this condition. | Remove the Off-Label Use: 5 of 5 (add to unsupported use) | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Octreotide | Meningioma | 2015.09 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Add to Use: Unsupported: While results from a small study of octreotide LAR for recurrent meningioma demonstrated partial response or stable disease in some patients, subsequent studies in recurrent/progressive meningioma have not demonstrated a benefit. Given the unknown natural history of meningioma, the role of somatostatin analogues in meningioma is unclear. | For the Use: 3 of 6 (Off-label use not added [no consensus]); Add to Use: Unsupported | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Pegfilgrastim | Prevention of chemotherapy-induced neutropenia in children | 2015.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to pediatric dosing addition to FDA labeling). | n/a | n/a |
| Nivolumab | Renal cell cancer, clear cell (advanced) | 2015.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Nivolumab | Melanoma, unresectable or metastatic (without BRAF mutation), first-line, single-agent therapy | 2015.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Uridine Triacetate | Fluorouracil overdose/overexposure | 2015.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Docetaxel | Cervical Cancer (recurrent) | 2016.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS |
Against off-label use: Evidence suggests a lack of support for this off-label use; additional studies are needed to further define the role of docetaxel in the management of this condition. | Remove the off-label use: 3 of 5 (Add to Use: Unsupported) | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Palbociclib | Breast cancer, advanced (second-line endocrine-based therapy) | 2016.03 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Fulvestrant | Breast cancer, advanced (second-line endocrine-based therapy) | 2016.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Cabozantinib | Renal cell carcinoma, advanced | 2016.05 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Ifosfamide | Head and neck cancer | 2016.09 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of ifosfamide for the treatment of head and neck cancer. | Remove the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Ifosfamide | Small cell lung cancer | 2016.09 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Corey Carter, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of ifosfamide for the treatment of small cell lung cancer. | Remove the off-label use: 5 of 5 (Add to Use: Unsupported) | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Nivolumab | Head and neck cancer, squamous cell (recurrent or metastatic) | 2016.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Mitomycin | Non-small cell lung cancer | 2016.11 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of mitomycin for the treatment of non-small cell lung cancer. | Remove the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Fluorouracil | Thymic cancers | 2017.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD. BCOP |
Against off-label use: A lack of evidence suggests a lack of support for this off-label use. | Remove the off-label use: 5 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Antithymocyte globulin (rabbit;Thymoglobulin) | Myelodysplastic syndrome (low risk; non-sideroblastic) | 2017.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Corey Carter, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD. BCOP |
Against off-label use: A lack of evidence for antithymocyte globulin (rabbit; Thymoglobulin) suggests a lack of support for this off-label use. | Remove the off-label use: 4 of 5 | No conflict of interest No conflict of interest No conflict of interest No conflict of interest No conflict of interest |
| Regorafenib | Hepatocellular carcinoma (intermediate or advanced) | 2017.05 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Pembrolizumab | Urothelial carcinoma (advanced) | 2017.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Dabrafenib | Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V600E mutation) | 2017.07 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Trametinib | Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V600E mutation) | 2017.07 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Tocilizumab | Cytokine release syndrome (due to CAR-T cell therapy) | 2017.09 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Vemurafenib | Erdheim-Chester disease, refractory (with BRAF V600E mutation) | 2017.11 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). | n/a | n/a |
| Busulfan (oral) | Chronic myeloid leukemia (palliative treatment) | 2017.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Heidi Trinkman, PharmD |
Against the use: Although palliative treatment of chromic myeloid leukemia (CML) is as an approved use in the manufacturer’s labeling for busulfan tablets, other contemporary therapies have replaced the use of oral busulfan for management of CML. According to the European LeukemiaNet Recommendations for Management of CML, treatments include tyrosine kinase inhibitors, omacetaxine, or allogeneic transplant, however, oral busulfan (unless part of a transplant conditioning regimen) is not recommended (Baccarani 2013). | Remove the off-label use: 4 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Cladribine | Chronic myeloid leukemia (palliative treatment) | 2017.12 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of cladribine for the treatment of chronic lymphocytic leukemia. | Remove the off-label use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Olaparib | Breast cancer, metastatic, HER2-negative, BRCA-mutated | 2018.01 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Abiraterone | Prostate cancer, metastatic or high-risk locally advanced, castration-sensitive | 2018.02 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Durvalumab | Non-small cell lung cancer (unresectable, locally advanced) | 2018.03 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Sargramostim | Hematopoietic radiation injury syndrome, acute | 2018.04 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Estramustine | Prostate cancer (metastatic castration-resistant) | 2018.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD Nick Link, PharmD, BCOP |
While estramustine is approved for palliative treatment of progressive or metastatic prostate cancer, guidelines from the American Society of Clinical Oncology/ Cancer Care Ontario (for systemic therapy in men w/metastatic castration-resistant prostate cancer) recommend against offering estramustine to men with metastatic castration-resistant prostate cancer due to a lack of benefit in survival or quality of life and an increased risk of toxicity (ASCO [Basch 2014]). | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Rituximab | Pemphigus vulgaris (newly diagnosed) | 2018.06 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved; (no panel vote needed – removed from off-label uses due to FDA approval) | n/a | n/a |
| Cetuximab | NSCLC, EGFR-expressing, advanced | 2018.07 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Elizabeth Connor, MD Omer Koc, MD Nick Link, PharmD, BCOP |
American Society of Clinical Oncology (ASCO) guidelines for Systemic Therapy for Stage IV Non-Small Cell Lung Cancer do not recommend cetuximab in the treatment of advanced NSCLC (ASCO [Masters 2015]). Cetuximab does not currently have an established role in the treatment of NSCLC either as a component of initial therapy or as second-line therapy. | Remove the off-label use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Vinblastine | Breast cancer | 2018.07 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Elizabeth Connor, MD Omer Koc, MD Nick Link, PharmD, BCOP |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of vinblastine for the treatment of refractory breast cancer. | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Nivolumab | Small cell lung cancer (progressive) | 2018.08 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to FDA approval) | n/a | n/a |
| Lenvatinib | Hepatocellular carcinoma (advanced) | 2018.08 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed – removed from off-label uses due to FDA approval) | n/a | n/a |
| Dactinomycin | Osteosarcoma | 2018.09 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Jennifer Thackray, PharmD, BCPPS, BCPS Mark Holdsworth, PharmD |
Limited (older) data exists for the use of chemotherapy regimens containing dactinomycin in the treatment of non-metastatic osteosarcoma; other contemporary chemotherapy regimens have replaced the use of dactinomycin-containing regimens for management of osteosarcoma. | Remove the off-label use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Bronchogenic carcinoma (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine in the palliative management of bronchogenic carcinoma. | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Chronic lymphocytic leukemia (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine in the palliative management of chronic lymphocytic leukemia (CLL). CLL guidelines and treatment recommendations do not include mechlorethamine as a treatment option (ESMO [Eichhorst 2015]; iwCLL [Hallek 2018]). | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Chronic myelocytic leukemia (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of chronic myelocytic (myeloid) leukemia (CML). CML guidelines and treatment recommendations do not include mechlorethamine as a treatment option (ELN [Baccarini 2013]; ESMO [Hochhaus 2017]). | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Lymphosarcomas (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Nick Link, PharmD, BCOP Jennifer Thackray, PharmD, BCPPS, BCPS |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of lymphosarcomas. | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Malignant effusion from metastatic carcinomas (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP Jennifer Thackray, PharmD, BCPPS, BCPS |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of malignant effusions. | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Mycosis fungoides (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Heidi Trinkman, PharmD |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of IV mechlorethamine in the palliative management of mycosis fungoides. A topical mechlorethamine product is commercially available and approved for treatment of mycosis fungoides-type cutaneous T-cell lymphoma. | Remove the use: 4 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mechlorethamine | Polycythemia vera (palliative treatment) | 2018.10 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Omer Koc, MD Polly Kintzel, PharmD, BCOP, BCPS Jordan Lundberg, PharmD, BCOP |
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of polycythemia vera. Chronic myeloproliferative neoplasm guidelines do not include mechlorethamine as a treatment option for polycythemia vera (ESMO [Vannucchi 2015]). | Remove the use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Mitoxantrone | Breast cancer (metastatic) | 2018.12 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Elizabeth Connor, MD Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Limited (older) data exists for the use of mitoxantrone in the treatment of metastatic breast cancer; other contemporary therapies have replaced the use of mitoxantrone for the treatment of metastatic breast cancer. | Remove the use: 4 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Pembrolizumab | Merkel cell carcinoma (advanced) | 2019.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Cabozantinib | Hepatocellular carcinoma (advanced) | 2019.01 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Pembrolizumab | Melanoma, stage III (adjuvant treatment) | 2019.02 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Atezolizumab | Small cell lung cancer (extensive-stage) | 2019.03 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Ado-trastuzumab emtansine | Breast cancer, early, HER2-positive (adjuvant therapy for residual disease) | 2019.05 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Ramucirumab | Hepatocellular carcinoma (advanced, relapsed/refractory) | 2019.05 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Vinblastine | Melanoma (metastatic) | 2019.09 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Although vinblastine has been previously used off-label as a component of the biochemotherapy regimen, CVD-interleukin-interferon (cisplatin, vinblastine, dacarbazine, aldesleukin, and interferon) for the treatment of metastatic melanoma, other contemporary therapies have replaced the use of this regimen in melanoma treatment. While combination biochemotherapy induced higher response rates and progression-free survival, this regimen did not improve overall survival or result in durable responses (Atkins 2008; Ives 2007). | Remove the off-label use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Cisplatin | Melanoma (metastatic) | 2019.09 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Polly Kintzel, PharmD, BCOP, BCPS Nick Link, PharmD, BCOP |
Although cisplatin has been previously used off-label as a component of the biochemotherapy regimen, CVD-interleukin-interferon (cisplatin, vinblastine, dacarbazine, aldesleukin, and interferon) for the treatment of metastatic melanoma, other contemporary therapies have replaced the use of this regimen in melanoma treatment. While combination biochemotherapy induced higher response rates and progression-free survival, this regimen did not improve overall survival or result in durable responses (Atkins 2008; Ives 2007). | Remove the off-label use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Olaparib | Pancreatic cancer, metastatic, BRCA-mutated (maintenance therapy) | 2020.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Interferon alfa-2b | Renal cell cancer | 2020.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Mark Holdsworth, PharmD Polly Kintzel, PharmD, BCOP, BCPS Omer Koc, MD |
Although interferon alfa-2b is included in combination with bevacizumab as a labeled use for bevacizumab (Avastin), other contemporary therapies have replaced the use of interferon in the management of renal cell cancers (RCC). The 2019 Society for Immunotherapy of Cancer (SITC) consensus statement on immunotherapy in the treatment of advanced renal cell carcinoma does not discuss interferons in the management of this condition (SITC [Rini 2019]). | Remove the off-label use: 4 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Interferon alfa-2b | Multiple myeloma | 2020.01 | Diedra Bragalone, PharmD, BCOP, BCPS Stephanie Minich, PharmD, BCOP Angela German, PharmD, BCOP Nick Link, PharmD, BCOP Jordan Lundberg, PharmD, BCOP |
Although interferon alfa-2b has been previous used as maintenance therapy for multiple myeloma, other contemporary therapies have replaced the use of interferon in the management of multiple myeloma. Interferon alfa-2b is not included in ASCO/CCO guidelines for the treatment of multiple myeloma (ASCO/CCO [Mikhael 2019]). | Remove the off-label use: 5 of 5 | No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest No Conflict of Interest |
| Luspatercept | Anemia due to lower-risk myelodysplastic syndromes with ring sideroblasts | 2020.04 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Encorafenib | Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) | 2020.04 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |
| Brigatinib | Non-small cell lung cancer, advanced (initial ALK-inhibitor therapy) | 2020.06 | Stephanie Minich, PharmD, BCOP Diedra Bragalone, PharmD, BCOP, BCPS |
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). | n/a | n/a |