Merck announces FDA granted priority review for supplemental sBLAs for Keytruda

Merck (MRK) announced that the FDA granted priority review for two supplemental Biologics License Applications, or sBLA, for KEYTRUDA, or pembrolizumab, and KEYTRUDA QLEX, or pembrolizumab and berahyaluronidase alfa-pmph, Merck’s anti-PD-1 therapy, each in combination with Padcev, or enfortumab vedotin-ejfv, for the treatment of patients with muscle-invasive bladder cancer, or MIBC, who are eligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act, or target action, date of August 17. If approved, these indications would expand the use of KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as the first perioperative treatments for patients with MIBC regardless of cisplatin eligibility and build on the previously approved indications of the combination for the treatment of patients with MIBC who are ineligible for cisplatin-based chemotherapy. The sBLAs are based on data from the Phase 3 KEYNOTE-B15 trial. KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer in the U.S., the European Union, Japan and several other countries.