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New Data Set Up Padcev For Potential Expanded Use

Regulatory Discussions Planned

 
• By Ian Haydock

Positive top-line data from a second pivotal trial cohort are set to support regulatory filings for the ADC in patients whose cancer has progressed after immunotherapy but are ineligible for cisplatin.

Bladder cancer medical concept as an anatomical organ symbol with microscopic malignant cells spreading in the human body as a health care 3D illustration.
Padcev Moves Forward In Bladder Cancer • Source: Shutterstock

Astellas Pharma, Inc. and Seagen Inc. (formerly Seattle Genetics) have announced positive top-line results from a second cohort of patients in a pivotal Phase II trial with Padcev (enfortumab vedotin) in advanced urothelial cancer, paving the way for a planned US filing for a supplemental indication.

The EV-201 trial found durable responses with monotherapy in patients with locally advanced or metastatic disease previously treated with an...

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