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
| Date | Article |
|---|
| Aug 17, 2018 |  FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer |
| Jul 11, 2018 | Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer |
| Apr 16, 2018 | FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma |
| Mar 6, 2018 | Bristol-Myers Squibb’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing |
| Dec 20, 2017 | 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, 2017 | Bristol-Myers Squibb’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib |
| 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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