Astellas and Seagen Report the NMPA’s Acceptance of BLA for Enfortumab Vedotin to Treat Urothelial Cancer
Shots:
- 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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
