Merck's KEYTRUDA and KEYTRUDA QLEX Get FDA Priority Review for Bladder Cancer Treatment

FDA Priority Review

The FDA has granted priority review for two supplemental Biologics License Applications for KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, targeting muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin-based chemotherapy. The target action date is set for April 7, 2026.

Clinical Trial Results

The applications are based on results from the Phase 3 KEYNOTE-905 trial, which demonstrated a 60% improvement in event-free survival and a 50% reduction in the risk of death compared to surgery alone. The trial also showed a significant increase in pathologic complete response rates.

Significance for MIBC Patients

If approved, these would be the first perioperative regimens to improve survival in this patient population, offering new treatment options for those who have not seen advances beyond surgery in decades.

Ongoing Research

Merck, in collaboration with Pfizer and Astellas, continues to evaluate KEYTRUDA across various stages of bladder cancer, with four additional Phase 3 studies underway. These studies aim to further explore the efficacy of KEYTRUDA in different cancer stages and combinations.