Opdivo Approval History

• FDA approved: Yes (First approved December 22nd, 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

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 renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, and MSI-H or dMMR metastatic colorectal cancer.

Development History and FDA Approval Process for Opdivo

Date	Article
Aug  1, 2017	Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
Feb  2, 2017	Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
Nov 10, 2016	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, 2016	Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma
Jan 23, 2016	Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Nov 23, 2015	FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma
Oct  9, 2015	FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer
Oct  1, 2015	BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma
Mar  4, 2015	FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer
Dec 22, 2014	FDA Approves Opdivo (nivolumab) for Advanced Melanoma
Dec  6, 2014	Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma
Nov 16, 2014	Study Comparing Opdivo (nivolumab) to Chemotherapy Demonstrates Survival Benefit
Oct 30, 2014	Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in NSCLC to be Presented
Oct  6, 2014	BMS Announces Collaboration to Evaluate Opdivo (nivolumab) in Combination to Treat Non-Small Cell Lung Cancer
Sep 26, 2014	Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab)

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