Pfizer, EMD Serono Seek FDA OK for Bavencio as First-Line Bladder Cancer Treatment
April 09 2020 - 6:53AM
Dow Jones News
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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