Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots:

• The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility
• Approval 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 (n=808)
• Trial showed a 47% reduction in the risk of EFS events (mEFS: not reached vs 48.5mos.), & a 35% decrease in death risk (mOS was not reached for either arm). It also showed a pCR rate of 55.8% vs 32.5%

Ref: Businesswire  |   Image: Merck, Pfizer & Astellas   | Press Release

Related News: Pfizer, Merck and Astellas Report P-III (KEYNOTE-B15) Trial Findings on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

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