Shots:
- The CHMP has recommended Astellas‘ Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states
- Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)
- In the trial, the combination showed improved EFS (1EP) by 60% vs surgery alone, with OS results (2EP) showing a 50% lower death risk
Ref: Astellas | Image: Astellas | Press Release
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