By: IPP Bureau
Last updated : October 23, 2025 6:18 pm
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
The U.S. Food and Drug Administration (FDA) has granted priority review to two Merck applications for its immunotherapy KEYTRUDA and its subcutaneous version, KEYTRUDA QLEX, combined with Padcev for muscle-invasive bladder cancer (MIBC). This designation follows positive Phase 3 trial results and expedites the FDA's review time from 10 to 6 months.
“New treatment options for muscle-invasive bladder cancer are critical, as patients ineligible for chemotherapy have not seen a significant advancement in decades,” said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “The FDA’s Priority Review brings us one step closer to potentially offering KEYTRUDA or KEYTRUDA QLEX in combination with Padcev to patients who face limited treatment choices and high unmet medical needs.”
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial (EV-303), conducted in collaboration with Pfizer and Astellas. The study evaluated perioperative treatment with KEYTRUDA plus Padcev compared with surgery alone in patients with MIBC who were not eligible for or declined cisplatin-based chemotherapy.
KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan, and several other countries, based on results from the Phase 3 KEYNOTE-A39 trial (EV-302). KEYTRUDA as a monotherapy is also approved in the U.S., EU, Japan, and other regions for certain patients with locally advanced or metastatic urothelial carcinoma or non-muscle-invasive bladder cancer (NMIBC).
Merck continues to advance a broad clinical development program evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive, and metastatic disease. Four ongoing Phase 3 studies—KEYNOTE-B15 (EV-304), KEYNOTE-866, KEYNOTE-992, and KEYNOTE-676—are exploring the role of KEYTRUDA in various treatment settings, including in combination with Bacillus Calmette-Guerin (BCG) for NMIBC.