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 cancer has 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 aged 12 years and older. Nivolumab is used alone or with ipilimumab to treat microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that has spread to other parts of the body and got worse after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan hydrochloride.¹
• Esophageal cancer or gastroesophageal junction adenocarcinoma. Nivolumab is used:
  • In adults whose esophageal cancer or gastroesophageal junction adenocarcinoma has been treated with a combination of chemotherapy and radiation therapy and then surgery to completely remove the cancer, but cancer cells were found in the removed tumor or lymph nodes.
  • In adults whose squamous cell carcinoma of the esophagus cannot be removed by surgery or has spread or come back after treatment with a fluoropyrimidine and platinum chemotherapy.
  • In adults with squamous cell carcinoma of the esophagus that cannot be removed by surgery or has spread to other parts of the body. It is given with either ipilimumab or a fluoropyrimidine and platinum chemotherapy as the first treatment.
• Gastric (stomach) cancer, gastroesophageal junction adenocarcinoma, or esophageal cancer that has spread. Nivolumab is used with a fluoropyrimidine and platinum chemotherapy.¹
• Malignant pleural mesothelioma. Nivolumab is used with ipilimumab as the first treatment in adults whose cancer cannot be removed by surgery.
• Melanoma. Nivolumab is used:
  • Alone or with ipilimumab in adults and children aged 12 years and older whose cancer cannot be removed by surgery or has spread to other parts of the body.
  • As adjuvant therapy in adults and children aged 12 years and older with one of the following stages of melanoma that has been completely removed by surgery: stage IIB, IIC, IIIA, IIIB, IIIC, IIID, or IV melanoma.
• Non-small cell lung cancer. Nivolumab is used:
  • As the first treatment with ipilimumab in adults whose cancer has spread to other parts of the body and has the PD-L1 protein but does not have mutations in the EGFR or ALK gene.
  • As the first treatment with ipilimumab and platinum chemotherapy in adults whose cancer has spread to other parts of the body or came back but does not have mutations in the EGFR or ALK gene.
  • In patients whose cancer has spread to other parts of the body 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 cancer got worse after treatment with FDA-approved therapy for these gene mutations.
  • With platinum chemotherapy before surgery in adults with early-stage cancer that can be removed by surgery.
• Renal cell carcinoma (a type of kidney cancer) that is advanced. Nivolumab is used:
  • In patients who have already received angiogenesis inhibitor therapy.
  • With cabozantinib-s-malate as the first treatment.
  • With ipilimumab as the first treatment in some patients.
• Squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Nivolumab is used in patients whose cancer got worse during or after treatment with platinum chemotherapy.
• Urothelial carcinoma (a type of cancer in the bladder or urinary tract) in adults. Nivolumab is used:
  • With cisplatin and gemcitabine as the first treatment in patients whose cancer cannot be removed by surgery or has spread to other parts of the body.
  • After surgery to remove the cancer in patients whose cancer has a high risk of coming back.
  • In patients whose cancer has spread and was treated with platinum chemotherapy, but it did not work or is no longer working, or that got worse after treatment with platinum chemotherapy.

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.

More About 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

Nivolumab Injections Could Make Treatment Easier for More People with Cancer

What Comes after NCI-MATCH? NCI’s New Precision Medicine Cancer Trials

A Better Biomarker for Cancer Immunotherapy?

Immunotherapy after Surgery Shows Long-Term Benefits for High-Risk Bladder Cancer

Immunotherapy and… Nothing Else? Studies Test Potential Paradigm Shift in Cancer Treatment

Targeted Therapy to Treat Cancer

Monoclonal Antibodies

Immune Checkpoint Inhibitors

Clinical Trials Accepting Patients

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