Astellas, Seagen: Cancer Treatment Padcev Supplemental Biologics License Application Gets FDA Priority Review
November 30 2023 - 6:04PM
Dow Jones News
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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