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FDA grants Priority Review for PADCEV plus Keytruda as perioperative treatment for muscle-invasive bladder cancer.

Market News
20 Apr 2026
PRNewsWire
View Source
Bullish
pluang ai news

The FDA has accepted for Priority Review a supplemental application for PADCEV (enfortumab vedotin) combined with Keytruda (pembrolizumab) as a perioperative treatment for muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. This follows positive Phase 3 EV-304 trial results showing significant reduction in tumor recurrence and death risk compared to standard chemotherapy. If approved, this would be the first perioperative regimen for MIBC patients irrespective of cisplatin eligibility, potentially setting a new standard of care. The FDA aims to decide by August 17, 2026, and the data will be reviewed by other global health authorities for regulatory filings.

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