Bristol-Myers Squibb’s application for expanded Opdivo indication ratified by EMA

Bristol-Myers Squibb has announced that its application for an expanded European indication for its PD-1 immune checkpoint inhibitor Opdivo has been ratified.

The European Medicines Agency (EMA) has been validated a type II variation application to extend the current indication for Opdivo to include the treatment of adult patients with advanced renal cell carcinoma after prior therapy.

This submission is based on data from the phase III study CheckMate -025, which showed the overall survival benefits of Opdivo versus the current standard of care in advanced or metastatic clear-cell renal cell carcinoma after prior anti-angiogenic treatment.

Dr Michael Giordano, senior vice-president and head of development for oncology at Bristol-Myers Squibb, said: "The validation of our application by the EMA is an important step in the regulatory review process in the European Union, and we will continue to work with the utmost speed to bring Opdivo to patients with this cancer."

Opdivo is the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014. It is now approved in more than 37 countries, including the US, Japan and the EU.