So Far, Still So Good For Seattle Genetics/Astellas’ Bladder Cancer ADC

Updated data from the Phase II EV-201 study of Seattle Genetics/Astellas Pharma’s novel ADC are strong enough to warrant accelerated approval, its investigators claim. An accelerated submission to the US FDA is due later this year.

Bladder cancer medical concept as an anatomical organ symbol with microscopic malignant cells spreading in the human body as a health care 3D illustration.
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Updated data from the first cohort of the Phase II EV-201 study of Seattle Genetics Inc./Astellas Pharma Inc.’s antibody-drug conjugate enfortumab vedotin continue to impress, with a confirmed 44% objective response rate and a median survival time of 11.7 months in a heavily pre-treated advanced urothelial cancer population.

Principal investigator Daniel Petrylak at Yale Cancer Center, who presented at the American Society of Clinical Oncology meeting in Chicago on 3 June, said enfortumab vedotin (EV) was the first...

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