U.S. License Holder:
Bristol-Myers Squibb
Date of License:
March-25-2011
Last Update:
Dec-15-2024
FDA-Approved Indications
YERVOY (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for:
Melanoma: Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older; Treatment of adult patients with unresectable or metastatic melanoma, in combination with nivolumab; Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy;
Renal Cell Carcinoma: Treatment of adult patients with intermediate or poor-risk, previously untreated advanced renal cell carcinoma, in combination with nivolumab;
Colorectal Cancer: Treatment of adult and pediatric patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in combination with nivolumab;
Hepatocellular Carcinoma: Treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab;
Non-Small Cell Lung Cancer (NSCLC): Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (greater than or equal to 1 percent) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab; Treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy;
Malignant Pleural Mesothelioma: Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab;
Esophageal Cancer: Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab.
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