US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Thursday that the US Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.

The FDA has set 7 April 2026 as the target action date.

The applications are supported by results from the Phase 3 KEYNOTE-905 trial, conducted with Pfizer (NYSE:PFE) and Astellas (TYO:4503). The study showed that the combination therapy improved event-free survival by 60%, reduced the risk of death by 50%, and increased pathologic complete response rates by 48% compared with surgery alone.

If approved, these regimens would be the first perioperative treatments to demonstrate a survival benefit in this patient population. The findings were presented at the European Society for Medical Oncology Congress, highlighting significant gains in both event-free and overall survival.

Merck continues to advance a broad clinical programme for KEYTRUDA across all stages of bladder cancer, including ongoing Phase 3 trials evaluating its use in non-muscle-invasive, muscle-invasive, and metastatic disease.