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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

Oct  2, 2020Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
May 26, 2020Approval 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, 2020Approval 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, 2020Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib
Jul 11, 2018Approval Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer
Apr 16, 2018Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma
Jul 24, 2017Approval FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
Jan 23, 2016Approval Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Oct 28, 2015Approval FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery
Oct  1, 2015Approval BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma
Mar 28, 2011Approval FDA Approves Yervoy for Late-Stage Melanoma
Nov  2, 2010Bristol-Myers Squibb Announces that the U.S. Food and Drug Administration Has Extended the Review Timeline for the Ipilimumab Biologics License Application
Aug 18, 2010Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma

Further information

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