Opdivo FDA 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, Esophageal Carcinoma, Malignant Pleural Mesothelioma
Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.
Development Timeline for Opdivo
| Date | Article |
|---|
| Apr 16, 2021 | Approval FDA Approves Opdivo (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma Regardless of PD-L1 Expression Status |
| Jan 22, 2021 | Approval U.S. Food and Drug Administration Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma |
| Oct 2, 2020 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma |
| Jun 10, 2020 | Approval FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy |
| May 26, 2020 | Approval 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, 2020 | Approval 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, 2020 | Approval FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib |
| Aug 17, 2018 | Approval FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer |
| Jul 11, 2018 | Approval Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer |
| Apr 16, 2018 | Approval 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 | Approval 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 | Approval 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 | Approval Bristol-Myers Squibb’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib |
| Aug 1, 2017 | Approval 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 | Approval Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma |
| Nov 10, 2016 | Approval 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 | Approval Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma |
| Jan 23, 2016 | Approval Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status |
| Nov 23, 2015 | Approval FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma |
| Oct 9, 2015 | Approval FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer |
| Oct 1, 2015 | Approval BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma |
| Mar 4, 2015 | Approval FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer |
| Dec 22, 2014 | Approval 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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