FDA accepts Keytruda/Padcev sBLA for priority review

The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Merck& Co’s (NYSE: MRK) blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC).

This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024.

Merck has submitted the sBLA based on results from the Phase III KEYNOTE-A39 trial, carried out in a research collaboration with Japan’s Astellas (TYO: 4502) and Padcev developer Seagen (Nasdaq: SEGN), currently the subject of a $43 billion acquisition by Pfizer (NYSE: PFE).