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Opdivo Approval History

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, and advanced squamous cell carcinoma of the head and neck.

Development History and FDA Approval Process for Opdivo

DateArticle
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)

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