By Stephen Nakrosis

The U.S. Food and Drug Administration on Friday said it approved Balversa for the treatment of certain adult patients with locally advanced or metastatic bladder cancer.

The FDA granted the approval of Balversa to Janssen Pharmaceutical, and also approved the therascreen FGFR RGQ RT-PCR Kit, developed by Qiagen Manchester, Ltd., for use as a companion diagnostic with Balversa.

The FDA said Balversa was the first targeted therapy for metastatic bladder cancer it approved.

Balversa was studied in a clinical trial that included 87 patients with locally advanced or metastatic bladder cancer, with certain genetic alterations, that had progressed following treatment with chemotherapy, the agency said.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

April 12, 2019 14:11 ET (18:11 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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