Opdivo FDA Approval History
Last updated by Judith Stewart, BPharm on March 15, 2022.
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, Esophageal Carcinoma, Malignant Pleural Mesothelioma, Gastric Cancer
Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-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, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.
Development timeline for Opdivo
| Date | Article |
|---|
| May 30, 2022 | Approval U.S. Food and Drug Administration Approves Two Opdivo (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma |
| Mar 7, 2022 | Approval U.S. Food and Drug Administration Approves Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer |
| Aug 20, 2021 | Approval U.S. Food and Drug Administration Approves Opdivo (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma |
| May 20, 2021 | Approval FDA Approves Opdivo (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy |
| 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 FDA Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma |
| Dec 29, 2020 | Approval Bristol Myers Squibb Statement on Opdivo (nivolumab) Small Cell Lung Cancer U.S. Indication |
| 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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