02:03 PM EDT, 03/28/2024 (MT Newswires) -- Pfizer ( PFE ) and Astellas Pharma's supplemental biologics license application for enfortumab vedotin in combination with Keytruda for the first-line treatment of advanced bladder cancer has been accepted by the China National Medical Products Administration's Center for Drug Evaluation, Astellas said Thursday.
If approved, enfortumab vedotin with Keytruda would be the first combination in China to offer an alternative to chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer, the company said.
The combination treatment was approved by the US Food and Drug Administration in December, Astellas said.
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