Merck has announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) as a potential treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The application is based on data from the Phase 3 KEYNOTE-604 trial.
The FDA set a Prescription Drug User Fee Act (PDUFA) date of February 13, 2025. The agency will review whether Keytruda, when used in combination with chemotherapy, should be approved as a first-line treatment for patients with ES-SCLC.
Dr. Gregory Lubiniecki, Vice President of Global Clinical Development at Merck Research Laboratories, said, “There remains a significant unmet need for new treatment options for extensive-stage small cell lung cancer. We are committed to developing new approaches that help address this aggressive form of lung cancer.”
Keytruda is already approved for several types of cancer, including other forms of lung cancer. The KEYNOTE-604 trial evaluated the drug in combination with etoposide and either cisplatin or carboplatin chemotherapy in patients with ES-SCLC. Results showed a statistically significant improvement in progression-free survival and a favorable trend in overall survival.
Small cell lung cancer is an aggressive form of lung cancer, accounting for about 15% of all lung cancer cases. Most patients are diagnosed at an advanced stage, and prognosis is typically poor, highlighting the need for more effective treatment options.
