Bristol-Myers Squibb’s Opdivo/Yervoy regimen accepted for new EU review

Bristol-Myers Squibb has announced that its Opdivo/Yervoy combination cancer therapy has been accepted for European regulatory review in a new indication.

The European Medicines Agency has validated a type II variation application seeking to expand the current indications for Opdivo plus Yervoy to include the treatment of intermediate and poor-risk patients with advanced renal cell carcinoma.

This filing is based on positive data from the phase III CheckMate-214 study, which was stopped 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: "The validation of this application for the Opdivo plus Yervoy combination attests to our commitment to bring immuno-oncology treatment to as many patients as possible.”

Renal cell carcinoma is the most common type of kidney cancer in adults, causing more than 100,000 deaths worldwide each year. It is approximately twice as common in men than in women, with the highest rates of the disease in North America and Europe.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.