Yervoy FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved March 25, 2011)
Brand name: Yervoy
Generic name: ipilimumab
Dosage form: Injection
Company: Bristol-Myers Squibb
Treatment for: Melanoma, Metastatic, Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma
Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of melanoma. Yervoy is also used in combination with Opdivo (nivolumab) for the treatment of advanced renal cell carcinoma, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, and malignant pleural mesothelioma.
Development timeline for Yervoy
| Date | Article |
|---|
| Oct 2, 2020 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma |
| May 26, 2020 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer |
| May 15, 2020 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1% |
| Mar 11, 2020 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib |
| Jul 11, 2018 | Approval Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer |
| Apr 16, 2018 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma |
| Jul 24, 2017 | Approval FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma |
| Jan 23, 2016 | Approval Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status |
| Oct 28, 2015 | Approval FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery |
| Oct 1, 2015 | Approval BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma |
| Mar 28, 2011 | Approval FDA Approves Yervoy for Late-Stage Melanoma |
| Nov 2, 2010 | Bristol-Myers Squibb Announces that the U.S. Food and Drug Administration Has Extended the Review Timeline for the Ipilimumab Biologics License Application |
| Aug 18, 2010 | Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma |
Further information
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