The FDA has approved the anti–PD-1 agent nivolumab (Opdivo) for the treatment of patients with advanced squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. The Food and Drug Administration (FDA) approved nivolumab (Opdivo®) on November 10 for the treatment of squamous cell cancer of the head and neck (SCCHN).. Nivolumab is already approved for the treatment of several other cancers. On 15 June 2018, … FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma. In March 2015, the U.S. FDA approved it for the treatment of squamous cell lung cancer. Of the 265 patients that could be evaluated, 52 (19.6%) had a confirmed objective response, meaning their tumors shr… Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® … The recommended doses for unresectable malignant pleural mesothelioma are nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression. Nivolumab is the second PD-1 inhibitor to gain approval in 2014. The FDA has granted an accelerated approval to nivolumab (Opdivo) for the treatment of patients with small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy and 1 other line of therapy. 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. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations before receiving nivolumab. OPDIVO (nivolumab) injection, for intravenous use Initial U.S. Approval: 2014 -----RECENT MAJOR CHANGES-----Indications and Usage (1) 3/2019 Dosage and Administration (2) 4/2019 Warnings and Precautions (5) 7/2018 Warnings and Precautions (5.10) 11/2018 Warnings and … In April 2015, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Nivolumab for metastatic melanoma as a monotherapy. Select one or more newsletters to continue. The approval comes 3 months ahead of the FDA’s scheduled decision date. Persons with disabilities having problems accessing the PDF files … … FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy Oncologist. BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma - October 1, 2015; FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer - March 4, 2015; FDA Approves Opdivo (nivolumab) for Advanced Melanoma - December 22, 2014; Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or … The approval, which is the first for SCLC in nearly 20 years, is contingent on findings from a confirmatory study. The nivolumab approval … All patients in the trial were treated with the same dose of nivolumab. OPDIVO (nivolumab) injection, for intravenous use . Patients were randomized to receive either nivolumab and ipilimumab for up to 2 years (n=303) or 6 cycles of combination chemotherapy with cisplatin or carboplatin plus pemetrexed (n=302). FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC. Median OS was 18.1 months (95% CI: 16.8, 21.5) versus 14.1 months (95% CI: 12.5, 16.2) (HR 0.74; 95% CI: 0.61, 0.89; p=0.002). Initial U.S. Approval: 2014 -----RECENT MAJOR CHANGES----- Indications and Usage (1) 3/2020 . Opdivo (nivolumab) Injection Company: Bristol-Myers Squibb Company Application No. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first … The FDA today granted approval to intravenous nivolumab (Opdivo, Bristol-Meyers Squibb), 360 mg every 3 weeks, plus ipilimumab (Yervoy), 1 mg/kg every 6 weeks, for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). In May, FDA approved regorafenib (Stivarga®) for patients with advanced liver cancer whose disease has progressed after treatment with sorafenib. View full prescribing information for OPDIVO.View full prescribing information for YERVOY. This review used the Real-Time Oncology Review pilot programme and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for the frontline treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK aberrations. FDA granted priority review to nivolumab for this application and granted the approval approximately eight weeks ahead of the goal date. This review used the Real-Time Oncology Review (RTOR) pilot program and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. Confirmed overall response rate per BICR was 40% (95% CI: 34, 45) and 43% (95% CI 37, 49) in the nivolumab plus ipilimumab and chemotherapy arms, respectively. Median response duration was 11.0 months in the nivolumab plus ipilimumab arm and 6.7 months in the chemotherapy arm. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:. Generic name: nivolumab The FDA approved nivolumab (Opdivo) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy, according to Bristol Meyers Squibb – the agent’s manufacturer. In a randomized 1:1 ratio, participants were administered either nivolumab plus ipilimumab plus 2 cycles of platinum-doublet chemotherapy or platinum-doublet chemotherapy alone. FDA Approved: Yes (First approved March 23, 2017) Brand name: Bavencio Generic name: avelumab Dosage form: Injection Company: EMD Serono, Inc. ¹This use is approved under FDA’s Accelerated Approval Program. The FDA has granted approval to nivolumab (Opdivo) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) after receiving prior fluoropyrimidine- and platinum-based chemotherapy, announced Bristol Myers Squibb. The FDA has approved nivolumab (Opdivo) plus ipilimumab (Yervoy) and 2 cycles of platinum-doublet chemotherapy for the frontline treatment of patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This new approval is for the use of nivolumab in patients with SCCHN that has progressed during chemotherapy with a platinum-based drug … The FDA has approved the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of patients with metastatic or recurrent non–small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%), as determined by an FDA-approved test, and who do not have an EGFR or ALK tumor aberration. Nivolumab … Bristol Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. FDA approval occurred approximately 5 months ahead of the goal date. Further, nivolumab and ipilimumab was approved by the FDA on May 15 as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L1 ≥ 1% as determined by an FDA-approved test. Drug Approval Package. FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The applications were granted priority review and … A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. FDA approval occurred approximately 5 months ahead of the goal date. Dosage and Administration (2) 3/2020 . Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/10/2020: SUPPL-71: Labeling-Package Insert On October 2, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. The applications were granted priority review and orphan product designation. May 27, 2020. This helps FDA inform … U.S. Food and Drug Administration Approves Opdivo®(nivolumab) + Yervoy®(ipilimumab)as the First and Only Immunotherapy Treatment for Previously Untreated … For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Switzerland’s Swissmedic. FDA Approved: Yes (First approved December 22, 2014) This approval is the second for Opdivo in the United States within three months, and is based on the results of CheckMate -017 and CheckMate -063. The application reviews are ongoing at the other regulatory agencies. For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter @FDAOncology. The FDA has approved the anti–PD-1 agent nivolumab (Opdivo) for the treatment of patients with advanced squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Bavencio FDA Approval History. This approval is based on efficacy results from the CHECKMATE-9LA trial, which randomized patients metastatic or relapsed NSCLC to either nivolumab plus ipilimumab with 2 cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy alone for 4 cycles (n = 358). On October 9, 2015, the FDA granted regular approval to nivolumab based on a favorable benefit-risk assessment for the treatment of patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. The approval of nivolumab in early 2015 by the US Food and Drug Administration (FDA) for the treatment of squamous cell non-small-cell lung cancer (NSCLC) marks a second approval for this drug, following a 2014 approval for metastatic melanoma.Approved 3 months ahead of schedule, nivolumab is the first immunotherapy to be approved for the treatment of lung cancer. FDA Grants Accelerated Approval to Nivolumab and Ipilimumab Combination For Hepatocellular Carcinoma (HCC) March 11, 2020. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. The .gov means it’s official.Federal government websites often end in .gov or .mil. Efficacy was investigated in CHECKMATE-743 (NCT02899299), a randomized, open-label trial in patients with unresectable malignant pleural mesothelioma and no prior anticancer therapy. Warnings and Precautions (5) 3/2020 . This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Home; Food; Drugs; Medical Devices; Radiation-Emitting Products; Vaccines, Blood & Biologics ; Animal & Veterinary; Cosmetics; Tobacco Products . : 125554 Approval Date: 12/22/2014. We comply with the HONcode standard for trustworthy health information -, Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma, Study Comparing Opdivo (nivolumab) to Chemotherapy Demonstrates Survival Benefit, Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in NSCLC to be Presented, BMS Announces Collaboration to Evaluate Opdivo (nivolumab) in Combination to Treat Non-Small Cell Lung Cancer, Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab). The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur: On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers … Like sorafenib, regorafenib is a tyrosine kinase inhibitor. FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Advanced Esophageal … FDA Home; Drugs; Drug Approvals and Databases; Drugs@FDA - Opdivo (nivolumab) Injection Company: Bristol-Myers Squibb Company Application No. An official website of the United States government, : From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Median progression-free survival per blinded independent central review (BICR) was 6.8 months (95% CI: 5.6, 7.4) in the nivolumab plus ipilimumab arm and 7.2 months (95% CI: 6.9, 8.1) in the chemotherapy arm (HR 1.0; 95% CI 0.82, 1.21). FDA Approves Nivolumab Plus Ipilimumab and Chemotherapy for First-Line Treatment of Metastatic NSCLC . Search FDA . Dosage form: Injection The most common adverse reactions (incidence ≥ 20%) in patients receiving the combination of nivolumab plus ipilimumab in CHECKMATE-743 were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and  pruritus. Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). OPDIVO (nivolumab) injection, for intravenous use Initial U.S. Approval: 2014 ... tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. This … 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.