What's Happening?
The U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase
alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv). These treatments are intended for patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The applications are supported by Phase 3 KEYNOTE-B15 trial results, which demonstrated significant improvements in event-free survival and overall survival. If approved, these regimens would be the first perioperative treatments for MIBC patients regardless of cisplatin eligibility, potentially setting new standards of care.
Why It's Important?
The priority review by the FDA highlights the potential of KEYTRUDA and Padcev to significantly impact the treatment landscape for muscle-invasive bladder cancer. This development could offer new hope for patients who face limited survival prospects even after surgery and chemotherapy. The approval of these regimens would expand treatment options and improve outcomes for patients with this aggressive form of cancer. The combination therapy has already shown survival benefits across multiple trials, indicating its potential to reshape treatment approaches and address unmet needs in genitourinary cancers.
What's Next?
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026, for the review of these applications. If approved, Merck plans to share the trial results with regulatory authorities worldwide for potential regulatory filings. The company is also conducting additional Phase 3 studies to evaluate KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive, and metastatic disease. These efforts are part of Merck's broader research initiative to transform treatment options for genitourinary cancers.
