New EC approval for Keytruda and Padcev combo

European Commission (EC) has approved Keytruda (pembrolizumab), Merck & Co’s (NYSE: MRK) anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.

The decision follows the adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending the combination as the preferred first-line treatment for these patients, regardless of platinum eligibility.

This approval by the EC also follows the positive recommendation from the Committee for Medicinal Products for Human Use received in July this year, which was based on results from the first interim analysis of the Phase III KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Pfizer (NYSE: PFE), which acquired the drug’s developer Seagen and Japan’s Astellas Pharma (TYO: 4503).