China's NMDA accepts enfortumab vedotin BLA for review
The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
The drug is being developed by Japanese drug major Astellas Pharma (TYO: 4503), and in the USA is partnered with Seagen (Nasdaq: SGEN).
Padcev (enfortumab vedotin-ejfv) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Padcev generated sales of around $243 million in the nine months to December 2022 for Astellas, and $451 million in full-year 2022 for Seagen.
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