CHMP supports approval of MSD's KEYTRUDA for urothelial carcinoma

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed the approval of MSD’s KEYTRUDA, combined with Padcev (enfortumab vedotin-ejfv), as a first-line treatment for urothelial carcinoma. This treatment is intended for adults with unresectable or metastatic urothelial carcinoma.

KEYTRUDA is known as an anti-programmed death cell protein-1 therapy, while Padcev is an antibody-drug conjugate. The CHMP’s favorable opinion is based on interim results from the Phase III KEYNOTE-A39 clinical trial. This trial was a collaborative endeavor involving MSD, Pfizer, and Astellas, revealing that the combination therapy significantly enhanced both overall survival and progression-free survival compared to traditional platinum-based chemotherapy.

The KEYTRUDA and Padcev regimen demonstrated a notable reduction in mortality risk by 53% and decreased the risk of disease progression or death by 55% when contrasted with the standard platinum-based chemotherapy. Following the CHMP’s recommendation, the European Commission will now review the request for marketing authorization in the European Union, with a decision anticipated by the third quarter of 2024.

Previously, KEYTRUDA received approval in the European Union as a monotherapy for specific types of urothelial carcinoma. In contrast, the combination therapy of KEYTRUDA plus Padcev was approved in the United States in December 2023. MSD, in partnership with Pfizer and Astellas, continues to explore the efficacy of the KEYTRUDA and Padcev combination through an extensive clinical development program. This includes two additional Phase III clinical trials, KEYNOTE-B15 and KEYNOTE-905, which are focused on muscle-invasive bladder cancer.

Dr. Eliav Barr, the senior vice-president and head of global clinical development and chief medical officer at Merck Research Laboratories, emphasized the significance of the CHMP’s positive opinion. He stated, “The CHMP’s positive opinion reinforces the landmark results from KEYNOTE-A39 and follows the recent adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending KEYTRUDA plus enfortumab vedotin as the preferred first-line treatment for patients with advanced or metastatic urothelial carcinoma, regardless of platinum eligibility. We look forward to the European Commission’s decision and are excited to be taking the first steps to provide a potential new first-line standard of care for the treatment of this disease in patients in the EU.”

This new development follows MSD’s recent acquisition of Eyebiotech (EyeBio), which has now become a subsidiary of the company. The positive recommendation from the CHMP marks a significant milestone in the ongoing efforts to improve treatment options for patients with advanced or metastatic urothelial carcinoma. The impending decision by the European Commission will be crucial in determining the future availability of this combination therapy within the European Union.

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