Astellas, Seagen: Cancer Treatment Padcev Supplemental Biologics License Application Gets FDA Priority Review

By Stephen Nakrosis

Astellas Pharma and Seagen said the Food and Drug Administration has accepted for priority review a supplemental biologics license application for Padcev in combination with Keytruda to treat certain adult patients with bladder cancer.

The combination therapy of Padcev, or enfortumab vedotin-ejfv, and Keytruda is being studied as a treatment for adult patients with locally advanced or metastatic urothelial cancer, the companies said. Keytruda, an immunotherapy marketed by Merck, works with the body's immune system to help fight cancer, the company said Thursday.

Results from a pivotal confirmatory trial found the combination "significantly extended overall survival and progression-free survival versus standard platinum containing chemotherapy," according to Astellas.

It is estimated that 82,290 people will be diagnosed with bladder cancer in the U.S. this year, according to the companies.

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

(END) Dow Jones Newswires

November 30, 2023 17:49 ET (22:49 GMT)

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