The U.S. Food and Drug Administration granted priority review for two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX® (pembrolizumab plus berahyaluronidase alfa) in combination with Padcev® (enfortumab vedotin‑ejfv) for the treatment of patients with muscle‑invasive bladder cancer (MIBC) who are ineligible for cisplatin‑based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of April 7 2026, indicating an accelerated review timeline for these applications.
The priority review designation follows data from the Phase 3 KEYNOTE‑905 (EV‑303) trial, which demonstrated a 60 % improvement in event‑free survival, a 50 % reduction in risk of death, and a 48 % increase in pathologic complete response rates compared with surgery alone. These results were presented at the European Society for Medical Oncology (ESMO) Congress and form the basis for the two sBLAs.
By receiving priority review, Merck could bring a new combination therapy to patients earlier than the standard 10‑month review process, potentially generating additional revenue and strengthening the oncology portfolio. The approval would expand the use of KEYTRUDA and KEYTRUDA QLEX beyond their current indications, reinforcing Merck’s position as a leader in immuno‑oncology and providing a new growth avenue in a high‑need therapeutic area.
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