Astellas and Seagen Report the NMPA’s Acceptance of BLA for Enfortumab Vedotin to Treat Urothelial Cancer
- The NMPA has accepted the BLA for Padcev (enfortumab vedotin), an ADC directed against Nectin-4 to treat patients with LA/mUC who received prior treatment with a PD-1/L1 inhibitor & Pt-based CT
- The submission was based on the P-II study (EV-203) evaluating enfortumab vedotin in 40 patients. The results showed that EV-203 met its 1EPs & demonstrated a statistical significance in ORR, efficacy & PK results were consistent with global data
- Acc. to non-clinical evidence, Padcev's anticancer activity is likely caused by its binding to Nectin-4-expressing cells, followed by the internalization & release of the anti-tumor agent MMAE into the cell that causes the cell to stop reproducing (cell cycle arrest) & leads to programmed cell death (apoptosis)
Ref: Astellas | Image: Astellas
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