By Colin Kellaher

 

Pfizer Inc. and Merck KGaA's EMD Serono unit on Thursday said they have filed a supplemental biologics license application with the U.S. Food and Drug Administration for Bavencio for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.

The companies said the agency granted breakthrough-therapy designation to Bavencio for the indication and is reviewing the application under its Real-Time Oncology Review pilot program.

Pfizer and EMD Serono said the filing is based on a phase III study of Bavencio that met its primary endpoint of overall survival.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Bladder cancer is the 10th most common cancer worldwide, and urothelial carcinoma accounts for about 90% of all bladder cancers.

Germany's Merck and New York-based Pfizer formed a strategic alliance in 2014 to jointly develop and commercialize Bavencio.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

April 09, 2020 06:38 ET (10:38 GMT)

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