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BioWorld - Friday, April 3, 2026
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Home » FDA grants accelerated approval for Padcev to treat urothelial cancer
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FDA grants accelerated approval for Padcev to treat urothelial cancer

Dec. 24, 2019
By Lee Landenberger
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
BioWorld Asia Regulatory Cancer U.S. FDA

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