Shots:
- The CHMP has recommended Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for pts with resectable muscle-invasive bladder cancer (MIBC); if approved, authorization would be valid in all 30 EEA states
- Opinion was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts
- Trial showed a 47% reduction in the risk of the risk of tumor recurrence, progression, or death & a 35% decrease in death risk; data were published in The NEJM
Ref: Astellas | Image: Astellas |Press Release
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