Bristol-Myers Squibb files for new approvals for Opdivo in EU and US

Bristol-Myers Squibb has announced that its filings for regulatory approval of new indications of its drug Opdivo have been accepted for review in the US and Europe.

The company has applied to expand the use of Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck, based on its strong performance in clinical trials.

In the CheckMate -141 clinical study, Opdivo was shown to have met its primary endpoint of enhancing overall survival rates, compared to the investigator's choice of therapy.

The US Food and Drug Administration has accepted a supplemental biologics licence application for the drug with a priority review status, while the European Medicines Agency has validated a type II variation application for the same patient population.

Dr Jean Viallet, global clinical research lead for oncology at Bristol-Myers Squibb, said: "These milestones are important steps in the regulatory processes, and we look forward to working with authorities in the US and Europe to offer Opdivo to this patient population."

The drug was approved in combination with Yervoy for the treatment of advanced melanoma earlier this year.