Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This approval comes on the heels of a successful research collaboration with Japan’s Astellas and Seagen, which is now part of Pfizer.
The European Commission’s decision was supported by compelling data from the Phase III KEYNOTE-A39 clinical trial, also known as EV-302. The combination therapy, consisting of Keytruda, a programmed death-1 (PD-1) inhibitor, and Padcev, a nectin-4-directed antibody-drug conjugate (ADC), demonstrated a marked improvement in both overall survival (OS) and progression-free survival (PFS) compared to platinum-based chemotherapy regimens, including gemcitabine plus cisplatin or carboplatin. The treatment duo was found to reduce the risk of death by 53%. This EC approval follows a similar green light from the U.S. Food and Drug Administration (FDA), which granted approval for the combination therapy for the same indication in December 2023. – Flcube.com
