The FDA based its approval on the results of the CheckMate-142 study, which was recentlypublishedin theLancet Oncology, asreportedbyMedscape Medical News. This was a phase 2, multicenter, open-label, single-arm clinical trial that evaluated nivolumab in 74 patients with locally determined dMMR ...
Treatment of metastatic SCLC that has progressed following therapy with platinum-based chemotherapy and ≥1 other line of therapy (designated an orphan drug by FDA for this cancer). Accelerated approval based on objective response rate and duration of response. Continued approval may be contingent on...
8.Approved Drugs: Nivolumab (Opdivo) for Hodgkin Lymphoma FDA, May 2016 9.Approved Drugs: Nivolumab for SCCHN FDA, Nov 2016 10.FDA Approves Nivolumab for Urothelial Carcinoma OncLive, Feb 2017 11.Opdivo Approval History Drugs.com, cited May 2016 12.EMA Press Release. New treatment for advanced...
Nivolumabis a fullyhuman immunoglobulin(Ig)G4monoclonal antibodytargeting PD-1 on activatedimmune cells, thereby preventing interaction with the cognate ligands PD-L1 and PD-L2; blocking this interaction interrupts the resulting inhibitory signal. Nivolumab was granted accelerated approval by the FDA in...
10.FDA Approves Nivolumab for Urothelial Carcinoma OncLive, Feb 2017 11.Opdivo Approval History Drugs.com, cited May 2016 12.EMA Press Release. New treatment for advanced form of kidney cancer EMA, Feb 2016 13.Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMM...
Ono Pharmaceuticals. (2015e).Opdivo (generic name: nivolumab) of Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Co., Ltd. obtained approval from the FDA for an expanded indication for patients with previously treated, unresectable, recurrent Non-Small-Cell Lung Cancer (NSCLC) and offered...
FDA-approved: Adult: Esophageal cancer Advanced or metastatic gastric cancer and gastroesophageal junction cancer Recurrent or metastatic squamous cell head and neck cancer Hepatocellular carcinoma Classical Hodgkin lymphoma Unresectable malignantpleuralmesothelioma ...
The FDA approved nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. The approval was based on results from the Phase 3, CheckMate -141 trial in which nivolumab demo...
In April 2018,the FDA approved the combination of nivolumab and ipilimumabas a frontline treatment for intermediate- and poor-risk patients with advanced RCC.2Additionally, in January 2021,the combination of cabozantinib and nivolumab earned FDA approvalfor the frontline treatment of patients ...
Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “These new findings from CheckMate -9ER and the recent FDA approval of the combination regimen are extremely encouraging as we further explore the potential ofCABOMETYXin combination with immunotherapies to help more ...