Nivolumab

FDA label information for this drug is available at DailyMed.

Use in Cancer

Nivolumab is approved to be used alone or with other drugs to treat:

• Classic Hodgkin lymphoma in adults whose disease has relapsed (come back) or has gotten worse after either:
  • An autologous stem cell transplant and treatment with brentuximab vedotin¹; or
  • At least three other types of treatment including an autologous stem cell transplant.¹
• Colorectal cancer in adults and children 12 years and older. It is used alone or with ipilimumab to treat metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that got worse after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan hydrochloride.¹
• Hepatocellular carcinoma (a type of liver cancer). It is used alone or with ipilimumab in patients who have already been treated with sorafenib.¹
• Melanoma. It is used:
  • In patients whose cancer cannot be removed by surgery or has metastasized. It is sometimes used with ipilimumab.
  • In patients who have had surgery to remove melanoma that has spread to the lymph nodes or has metastasized.
• Non-small cell lung cancer. It is used:
  • As first-line therapy with ipilimumab in adults whose cancer is metastatic and has the PD-L1 protein but does not have mutations in the EGFR or ALK gene.
  • As first-line therapy with ipilimumab and platinum chemotherapy in adults whose cancer is metastatic or recurrent but does not have mutations in the EGFR or ALK gene.
  • In patients whose cancer is metastatic and has gotten worse during or after treatment with platinum chemotherapy. Patients whose cancer has a mutation in the EGFR or ALK gene should receive nivolumab only if their disease got worse after treatment with FDA-approved therapy for these gene mutations.
• Renal cell carcinoma (a type of kidney cancer) that is advanced. It is used:
  • In patients who have already received angiogenesis inhibitor therapy.
  • With ipilimumab in some patients with renal cell carcinoma that has not been treated.
• Small cell lung cancer that has metastasized. It is used in patients whose cancer got worse after treatment with platinum chemotherapy and at least one other therapy.¹
• Squamous cell carcinoma of the esophagus that cannot be removed by surgery and has either metastasized or recurred after treatment with a fluoropyrimidine and platinum chemotherapy.¹
• Squamous cell carcinoma of the head and neck that has metastasized or recurred in patients whose disease got worse during or after treatment with platinum chemotherapy.
• Urothelial carcinoma (a type of bladder cancer) that is locally advanced or has metastasized. It is used in patients whose cancer got worse during or after treatment with platinum chemotherapy.¹

¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that nivolumab provides a clinical benefit in these patients.

Nivolumab is also being studied in the treatment of other types of cancer.

More About Nivolumab

Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.

MedlinePlus Information on Nivolumab - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Research Results and Related Resources

Monoclonal Antibodies

Immune Checkpoint Inhibitors

Study Tests Immunotherapy in People with Cancer and Autoimmune Diseases

Targeted Therapy–Immunotherapy Combinations Effective for Advanced Kidney Cancer

NCI-MATCH Update: More Labs, New Arms, and Initial Findings

Nivolumab and Ipilimumab Effective against Melanoma That Has Spread to the Brain

Combination of Immunotherapy Drugs Approved for Metastatic Colorectal Cancer

Clinical Trials Accepting Patients

Find Clinical Trials for Nivolumab - Check for trials from NCI's list of cancer clinical trials now accepting patients.