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Drug Name Product Label Version Indications (excerpted from product labeling)

Atezolizumab

TECENTRIQ (atezolizumab) injection, for intravenous use; May 2016 product label. Genentech Inc., A Member of the Roche Group, South San Francisco, CA

TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • Have disease progression during or following platinum-containing chemotherapy.

  • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

    • This indication is approved under accelerated approval based on tumor response rate and durability of response.

    • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Cabozantinib

CABOMETYX (cabozantinib) tablets, for oral use; April 2016 product label. Exelixis, Inc. South San Francisco, CA

CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Venetoclax

VENCLEXTA (venetoclax) tablets, for oral use; April 2016 product label. Marketed by AbbVie, Inc. and Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA

VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

  • This indication is approved under accelerated approval based on overall response rate.

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Defibrotide sodium

DEFITELIO (defibrotide sodium) injection, for intravenous use; March 2016 product label. Jazz Pharmaceuticals, Inc., Palo Alto, CA

DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

Crizotinib

XALKORI® (crizotinib) capsules, for oral use; April 2016 product label. Pfizer Labs, Division of Pfizer, Inc., New York, NY

ALK-Positive Metastatic NSCLC

  • XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

ROS1-Positive Metastatic NSCLC

  • XALKORI is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive.

Everolimus

AFINITOR® (everolimus) tablets for oral administration [and] AFINITOR® DISPERZ (everolimus tablets for oral suspension); June 2016 product label. Novartis Pharmaceuticals Corporation, East Hanover, NJ

Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC)

  • AFINITOR® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.

Advanced Neuroendocrine Tumors (NET)

  • AFINITOR® is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.

  • AFINITOR® is indicated for the treatment of adult patients with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.

  • AFINITOR® is not indicated for the treatment of patients with functional carcinoid tumors.

Advanced Renal Cell Carcinoma (RCC)

  • AFINITOR® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)

  • AFINITOR® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

Subependymal Giant Cell Astrocytoma (SEGA) with Tuberous Sclerosis Complex (TSC)

  • AFINITOR® Tablets and AFINITOR® DISPERZ are indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

Obinutuzumab

GAZYVA® (obinutuzumab) injection, for intravenous infusion; February 2016 product label. Genentech Inc., A Member of the Roche Group, South San Francisco, CA

Chronic Lymphocytic Leukemia

  • GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

Follicular Lymphoma

  • GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.

Eribulin

HALAVEN® (eribulin mesylate) injection, for intravenous use; January 2016 product label. Eisai, Inc., Woodcliff Lake, NJ

Metastatic Breast Cancer

  • HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Liposarcoma

  • HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

Ofatumumab

ARZERRA® (ofatumumab) injection, for intravenous use; January 2016 product label. Novartis Pharmaceuticals Corporation, East Hanover, NJ

Previously Untreated Chronic Lymphocytic Leukemia

  • ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

Extended Treatment in CLL

  • ARZERRA is indicated for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.

Refractory CLL

  • ARZERRA is indicated for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

Alectinib

ALECENSA® (alectinib) capsules, for oral use; December 2015 product label. Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA

ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

  • This indication is approved under accelerated approval based on tumor response rate and duration of response.

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Uridine triacetate

VISTOGARD® (uridine triacetate) oral granules; December 2015 product label. Wellstat Therapeutics Corporation, Gaithersburg, MD

VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients:

  • following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or

  • who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

    Limitations of Use:

    • VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.

    • The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

Elotuzumab

EMPLICITI (elotuzumab) for injection, for intravenous use; November 2015 product label. Bristol-Myers Squibb Company, Princeton, NJ

EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

Necitumumab

PORTRAZZA (necitumumab) injection, for intravenous use; November 2015 product label. Lilly USA, LLC, Indianapolis, IN

PORTRAZZA is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer.

  • Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer.

Ixazomib

NINLARO® (ixazomib) capsules, for oral use; November 2015 product label. Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Daratumumab

DARZALEX (daratumumab) injection, for intravenous use; November 2015 product label. Janssen Biotech, Inc., Horsham, PA

DARZALEX is indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

  • This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Osimertinib

TAGRISSO (osimertinib) tablet, for oral use; November 2015 product label. AstraZeneca Pharmaceuticals LP, Wilmington DE

TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

  • This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Cobimetinib

COTELLIC® (cobimetinib) tablets, for oral use; May 2016 product label. Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA

COTELLIC® is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

Ipilimumab

YERVOY® (ipilimumab) injection, for intravenous use; October 2015 product label. Bristol-Myers Squibb Company, Princeton, NJ

Unresectable or Metastatic Melanoma

  • YERVOY is indicated for the treatment of unresectable or metastatic melanoma.

Adjuvant Treatment of Melanoma

  • YERVOY is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Nivolumab

OPDIVO® (nivolumab) injection, for intravenous use; May 2016 product label. Bristol-Myers Squibb Company, Princeton, NJ

Unresectable or Metastatic Melanoma

  • OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

  • OPDIVO (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

    • This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

  • OPDIVO (nivolumab), in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma.

    • This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Metastatic Non-Small Cell Lung Cancer

  • OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

    • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Renal Cell Carcinoma

  • OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Classical Hodgkin Lymphoma

  • OPDIVO (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin.

    • This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Irinotecan Liposome for Injection

ONIVYDE (irinotecan liposome injection), for intravenous use; October 2015 product label. Merrimack Pharmaceuticals Inc., Cambridge, MA

ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

Trabectedin

YONDELIS® (trabectedin) for injection, for intravenous use; October 2015 product label. Jansen Products, LP, Horsham, PA

YONDELIS® is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

Talimogene laherparepvec

IMLYGIC (talimogene laherparepvec) Suspension for intralesional injection; October 2015 product label. BioVex, Inc., a subsidiary of Amgen Inc., Thousand Oaks, CA

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

  • Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

Belinostat

BELEODAQ® (belinostat) for injection, for intravenous administration; July 2014 product label. Spectrum Pharmaceuticals, Inc., Irvine, CA

Beleodaq is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

  • This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established.

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Blinatumomab

BLINCYTO (blinatumomab) for injection, for intravenous use; December 2014 product label. Amgen Inc., Thousand Oaks, CA

BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

  • This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Dinutuximab

UNITUXIN (dinutuximab) injection, for intravenous use; March 2015 product label. United Therapeutics Corp. Silver Spring, MD

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) [aldesleukin] and 13-cis-retinoic acid (RA [isotretinoin]), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Lanreotide acetate

SOMATULINE® DEPOT (lanreotide) INJECTION; December 2014 product label. Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ

Acromegaly

  • SOMATULINE DEPOT (lanreotide) Injection 60 mg, 90 mg, and 120 mg is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.

Gastroenteropancreatic neuroendocrine tumors

  • SOMATULINE DEPOT Injection 120 mg is indicated for the treatment of patients with unresectable, well or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

Pembrolizumab

KEYTRUDA® (pembrolizumab) for injection, for intravenous use [and] KEYTRUDA® (pembrolizumab) injection, for intravenous use; December 2015 product label. Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ

Melanoma

  • KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic Melanoma.

Non-Small Cell Lung Cancer

  • KEYTRUDA is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

    • This indication is approved under accelerated approval based on tumor response rate and durability of response.

    • An improvement in survival or disease-related symptoms has not yet been established.

    • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Ramucirumab

CYRAMZA® (ramucirumab) injection, for intravenous use; April 2015 product label. Eli Lilly and Company, Indianapolis, IN

Gastric Cancer

  • CYRAMZA® as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer

  • CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy.

    • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer

  • CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and …fluorouracil ), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Siltuximab

SYLVANT (siltuximab) for Injection, for Intravenous Infusion; November 2015 product label. Janssen Biotech, Inc., Horsham, PA

SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

  • Limitation of Use: SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.

Ceritinib

ZYKADIA® capsules ZYKADIA (ceritinib) capsules, for oral use; July 2015 product label. Novartis Pharmaceuticals Corporation, East Hanover, NJ

ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

  • This indication is approved under accelerated approval based on tumor response rate and duration of response.

  • An improvement in survival or disease-related symptoms has not been established.

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Dabrafenib

TAFINLAR® (dabrafenib) capsules, for oral use; June 2016 product label. Novartis Pharmaceuticals Corporation, East Hanover, NJ

BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma

  • TAFINLAR® is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

  • TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

    • Limitation of Use: TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma.

Idelalisib

ZYDELIG® (idelalisib) tablets, for oral use; July 2014 product label. Gilead Sciences, Inc., Foster City, CA

Relapsed Chronic Lymphocytic Leukemia

  • Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

Relapsed Follicular B-cell non-Hodgkin Lymphoma

  • Zydelig is indicated for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies.

    • Accelerated approval was granted for this indication based on Overall Response Rate. An improvement in patient survival or disease related symptoms has not been established.

    • Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Relapsed Small Lymphocytic Lymphoma

  • Zydelig is indicated for the treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.

    • Accelerated approval was granted for this indication based on Overall Response Rate.

    • An improvement in patient survival or disease related symptoms has not been established.

    • Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Lenvatinib mesylate

LENVIMA® (lenvatinib) capsules, for oral use; May 2016 product label. Eisai, Inc., Woodcliff Lake, NJ

Differentiated Thyroid Cancer

  • LENVIMA is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC.

Renal Cell Carcinoma

  • LENVIMA is indicated in combination with everolimus for the treatment of patients with advanced RCC following one prior anti-angiogenic therapy.

Olaparib

Lynparza (olaparib) capsules, for oral use; December 2014 product label. AstraZeneca Pharmaceuticals LP, Wilmington DE

Lynparza is indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

  • The indication is approved under accelerated approval based on objective response rate and duration of response.

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Palbociclib

IBRANCE® (palbociclib) capsules, for oral use; February 2016 product label. Pfizer Labs, Division of Pfizer, Inc., New York, NY

IBRANCE is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with:

  • letrozole as initial endocrine based therapy in postmenopausal women, or

  • fulvestrant in women with disease progression following endocrine therapy.

    • The indication in combination with letrozole is approved under accelerated approval based on progression-free survival (PFS).

    • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Panobinostat

FARYDAK® (panobinostat) capsules, for oral use; June 2016 product label. Novartis Pharmaceuticals Corporation, East Hanover, NJ

FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.

  • This indication is approved under accelerated approval based on progression free survival.

  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Trametinib

MEKINIST® (trametinib) tablets, for oral use; November 2015 product label. Novartis Pharmaceuticals Corporation, East Hanover, NJ

MEKINIST® is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

  • Limitation of use: MEKINIST is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.

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