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Bristol Myers' Nivolumab Approved By EU For Kidney Cancer Treatment

Bristol Myers Squibb Co. (BMY) Wednesday said the European Commission has approved its drug nivolumab in combination with cabozantinib as a treatment for patients with advanced renal cell carcinoma.

The New York-based pharmaceutical company said the EC's decision was based on results from a late-stage trial, which demonstrated superior efficacy with nivolumab in combination with Cabometyx versus sunitinib across three key endpoints: progression-free survival and objective response rate and overall survival.

The combination of nivolumab and Cabometyx was well tolerated, with safety reflective of the known profiles of both medicines and a low rate of treatment-related adverse events leading to discontinuation.

"With this approval, we can now offer patients two different nivolumab-based combinations that have demonstrated significant survival benefits versus sunitinib," said Dana Walker, vice president, development program lead, genitourinary cancers, Bristol Myers Squibb.

Nivolumab in combination with Cabometyx was approved for the first-line treatment of advanced renal cell carcinoma by the U.S. Food and Drug Administration in January 2021.

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