Posted by Michael Wonder on 06 Jun 2017
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
10 November 2016 - Opdivo is the first and only immuno-oncology treatment proven in a Phase 3 trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer who had been previously treated with platinum-based therapy.
Bristol-Myers Squibb Company announced today that the U.S. FDA has approved Opdivo (nivolumab) injection, for intravenous use, 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.
Opdivo is the first and only immuno-oncology treatment proven in a Phase 3 trial to significantly extend overall survival (OS) for these patients. In oncology clinical trials, OS is considered the gold standard primary endpoint to evaluate the outcome of any therapy.
