EMA to review Opdivo/Yervoy in expanded indications

Amy Schofield 29 November 2017

Bristol-Myers Squibb has announced the validation of its type II variation application by the European Medicines Agency.

The application seeks to expand the current indications for Opdivo (nivolumab) plus Yervoy (ipilimumab) to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma, marking the beginning of the EMA's centralised review process.

Renal cell carcinoma is the most common type of kidney cancer in adults, causing more than 100,000 deaths worldwide each year.

The application is based on data from the phase 3 CheckMate-214 study. The study was halted early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival.

Murdo Gordon, executive vice-president and chief commercial officer at Bristol-Myers Squibb, said that the validation "attests to our commitment to bring immuno-oncology treatment to as many patients as possible".


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