ALPMY

Astellas : FDA Grants Priority Review For SBLA Of Padcev Combination For Bladder Cancer Treatment

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) and Seagen Inc. (SGEN) said that the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application or sBLA for Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.

The FDA said it is reviewing the application under its Real-Time Oncology Review program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. If approved, the combination would be the first treatment option for cisplatin eligible and ineligible patients.

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