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Opdivo Approval History

FDA Approved: Yes (First approved December 22, 2014)
Brand name: Opdivo
Generic name: nivolumab
Dosage form: Injection
Company: Bristol-Myers Squibb Company
Treatment for: Melanoma, Metastatic, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin's Lymphoma, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Small Cell Lung Cancer

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Development History and FDA Approval Process for Opdivo

DateArticle
Aug 17, 2018Approval FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer
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
Mar  6, 2018Approval Bristol-Myers Squibb’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing
Dec 20, 2017Approval Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
Sep 22, 2017Approval Bristol-Myers Squibb’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib
Aug  1, 2017Approval Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
Feb  2, 2017Approval Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
Nov 10, 2016Approval Bristol-Myers Squibb’s Opdivo (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer
May 17, 2016Approval Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma
Jan 23, 2016Approval Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Nov 23, 2015Approval FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma
Oct  9, 2015Approval FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer
Oct  1, 2015Approval BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma
Mar  4, 2015Approval FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer
Dec 22, 2014Approval FDA Approves Opdivo (nivolumab) for Advanced Melanoma
Dec  6, 2014Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma
Nov 16, 2014Study Comparing Opdivo (nivolumab) to Chemotherapy Demonstrates Survival Benefit
Oct 30, 2014Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in NSCLC to be Presented
Oct  6, 2014BMS Announces Collaboration to Evaluate Opdivo (nivolumab) in Combination to Treat Non-Small Cell Lung Cancer
Sep 26, 2014Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab)

Further information

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