Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved its Opdivo intravenous injection for patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
The approval is for patients with disease progression who are on or previously received platinum-based therapy. The drug is the first immuno-oncology treatment to significantly extend overall survival for these patients, as shown in a phase III trial, according to the company.
Squamous cell carcinoma of the head and neck is the most common form of head and neck cancer, and the relative five-year survival rate for metastatic head and neck cancers is less than 38%, Bristol-Myers Squibb said.