Ipilimumab was approved by the U.S. Food and Drug Administration (FDA) in March 2011, to treat people with late-stage melanoma that has spread or cannot be removed by surgery. It was later approved by the US FDA on October 28, 2015, for stage 3 patients as adjuvant therapy. On February 1, 2012, Health Canada approved ipilimumab for “treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease.” Ipilimumab was approved in the European Union (EU), for second line treatment of metastatic melanoma in November 2012.

Nivolumab, in combination with ipilimumab is indicated for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

Ipilimumab, in combination with nivolumab, is indicated for the treatment of adults and adolescents twelve years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Ipilimumab, in combination with nivolumab, is indicated for the treatment of people with hepatocellular carcinoma who have been previously treated with sorafenib.

Ipilimumab, in combination with nivolumab, is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test.

In October 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.[30] This is the first drug regimen approved for mesothelioma in sixteen years and the second FDA-approved systemic therapy for mesothelioma.

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