FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

European Commission Approves Bristol-Myers Squibb’s Opdivo

May 8, 2017
A A

Bristol-Myers Squibb was awarded European Commission approval of Opdivo (nivolumab) as a monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.

The drug was approved based on a Phase III trial which showed significant improvement in overall survival for these patients.

Opdivo uses the body’s immune system to help restore anti-tumor immune response.

The most frequent serious adverse reactions reported in at least 2 percent of patients receiving Opdivo were pneumonia, dyspnea, aspiration pneumonia, respiratory failure, respiratory tract infection and sepsis.

View today's stories