ALPMF - Merck Seagen Astellas combo bladder cancer treatment sBLAs accepted by FDA

• The US FDA has accepted supplemental Biologics License Applications from Merck ( NYSE: MRK ), Seagen ( NASDAQ: SGEN ), and Astellas ( OTCPK:ALPMF )( OTCPK:ALPMY ) for a combination of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) for urothelial cancer.
• The FDA set an action date of April 21, 2023 for the applications.
• The combination was granted Breakthrough Therapy designation in 2020.
• An ongoing phase 3 trial, EV-302, is evaluating the combination in those with previously untreated advanced urothelial cancer. The study's purpose is to serve as the confirmatory trial for a potential accelerated approval as well as the the basis for global registration.
• Read why Seeking Alpha contributor RoseNose views Merck ( MRK ) as a hold.

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