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Enfortumab Progresses As US Accelerated Approval Eyed In Urothelial Cancer

 
• By Ian Haydock

Astellas and Seattle Genetics now expect key top-line data on their antibody-drug conjugate in urothelial cancer in the first half of next year, as pivotal trials in support of a planned US accelerated approval progress.

Cancer cells on scientific background.3d illustration
ENFORTUMAB VEDOTIN MOVES AHEAD IN UROTHELIAL CANCER • Source: Shutterstock

Following encouraging Phase I results, Astellas Pharma Inc. and Seattle Genetics Inc. now expect key top-line data from a pivotal Phase II trial with their antibody-drug conjugate (ADC) enfortumab vedotin in the first half of next year, which will be used to support a planned US accelerated approval filing for later-line use in urothelial cancer.

The companies said enrollment had now been completed in the EV-201 study in patients with locally advanced or metastatic disease who have been treated previously with both platinum-based chemotherapy and...

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