Shots:
- The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026)
- sBLA 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 47% reduction in the risk of tumor recurrence, progression or death, & a 35% decrease in death risk. It also showed a pCR rate of 55.8% vs 32.5% at the time of surgery; results were presented at ASCO GU’26 & will be shared with regulators for potential filing
Ref: Pfizer | Image: Pfizer & Astellas | Press Release
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