FDA Grants Priority Review for Merck's KEYTRUDA and KEYTRUDA QLEX Combination Therapy
The U.S. Food and Drug Administration (FDA) has granted priority review for Merck & Co., Inc.'s two supplemental Biologics License Applications (sBLAs) for its leading immunotherapy, KEYTRUDA® (pembrolizumab), and KEYTRUDA QLEX™ (a combination of pembrolizumab and berahyaluronidase alfa-pmph). This significant move is aimed at expanding treatment options for patients suffering from muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA has set a target action date of August 17, 2026, under the Prescription Drug User Fee Act (PDUFA).
1. Expanded Treatment Options for Muscle-Invasive Bladder Cancer
If approved, these applications will enable KEYTRUDA and KEYTRUDA QLEX to be used in combination with Padcev® (enfortumab vedotin-ejfv) as the first perioperative treatments for patients with MIBC, irrespective of their cisplatin eligibility status. Currently, the combination of KEYTRUDA and Padcev is already approved for patients who are ineligible for cisplatin-based chemotherapy.
Dr. Marjorie Green, Senior Vice President and Head of Oncology at Merck Research Laboratories, expressed optimism about the potential impact of this expanded indication. "Results from the KEYNOTE-B15 trial challenge long-held expectations for patients with muscle-invasive bladder cancer," Dr. Green stated. She emphasized the need for new treatment strategies, as many patients still experience disease progression even after undergoing curative-intent surgery and chemotherapy.
2. Evidence-Based Approvals
The sBLAs are based on promising data from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas. This trial enrolled 808 patients and was presented at the recent American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. Merck plans to share these important results with regulatory authorities worldwide to facilitate additional regulatory filings.
Currently, KEYTRUDA in combination with Padcev is approved for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) in the U.S., the European Union, Japan, and several other countries. The combination has shown an overall survival benefit across three Phase 3 trials in bladder cancer, including KEYNOTE-905 and KEYNOTE-A39.
3. Ongoing Research and Development
Merck remains committed to advancing research in genitourinary cancers, which account for an estimated 2.6 million new cancer diagnoses each year globally. The company boasts a robust clinical development program with over 50 ongoing trials involving more than 22,000 patients, exploring various treatment strategies across different stages of bladder cancer, including non-muscle-invasive and metastatic diseases.
In addition to KEYNOTE-B15, two other Phase 3 trials, KEYNOTE-866 and KEYNOTE-992, are currently evaluating KEYTRUDA in the context of muscle-invasive bladder cancer. Merck's commitment to innovation is evident in its extensive pipeline, which seeks to address unmet needs in cancer treatment.
4. What This Means for Patients
The implications of this FDA priority review are profound for patients with muscle-invasive bladder cancer. With about 25% of newly diagnosed bladder cancer cases classified as muscle-invasive, the need for effective treatment alternatives is urgent. The standard of care has traditionally involved neoadjuvant cisplatin-based chemotherapy followed by surgery; however, nearly half of these patients experience recurrence.
The potential approval of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev could reshape treatment paradigms and improve outcomes for a patient population that has historically faced limited options.
5. Conclusion
Merck's focus on innovative cancer therapies continues to gain momentum with the FDA's recent decision. The anticipated expansion of KEYTRUDA and KEYTRUDA QLEX as effective treatment options for muscle-invasive bladder cancer marks a significant step forward in the fight against this aggressive disease. As Merck proceeds with its regulatory submissions and ongoing research, the hope remains that these advancements will lead to improved survival rates and quality of life for patients battling cancer.
