Shots:
- FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible pts with MIBC, before the PDUFA action date (Apr 07, 2026)
- Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed by 6 cycles of the combination, then 8 cycles of Keytruda alone)
- Trial showed improved EFS (1EP) by 60% vs surgery alone, with EFS rates of 74.7% vs 39.4%; mEFS not reached vs 15.7mos. OS results (2EP) showed a 50% lower death risk, with 2yr. OS of 79.7% vs 63.1% & mOS not reached vs 41.7mos.; data presented at ESMO’25
Ref: Pfizer | Image: Pfizer & Astellas | Press Release
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