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EMA validates Bristol-Myers application to expand Opdivo combo indication

Bristol-Myers Squibb Co. said the European Medicines Agency validated its type II variation application seeking to expand the indications of a combination of its cancer drugs Opdivo and Yervoy.

The application seeks to expand current indications for the combination to include the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma, a type of kidney cancer.

The application is based on data from the phase 3 CheckMate -214 study, which was stopped early due to the recommendation of an independent data monitoring committee after the drug combination showed superior life expectancy.