Posted by Michael Wonder on 18 Jul 2016
Bristol-Myers Squibb announces regulatory updates for Opdivo (nivolumab) in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
18 July 2016 - Bristol-Myers Squibb Company announced today U.S. and European marketing applications to expand the use of Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck were accepted for filing by the U.S. FDA and validated by the EMA.
In the U.S., the FDA accepted the Company’s supplemental biologics license application for Opdivo in squamous cell carcinome of the head and neck with priority review, and previously granted the agent breakthrough therapy designation in April 2016. The projected FDA action date is November 11, 2016.
In Europe, the EMA validated a type II variation application for the same patient population. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
