MHRA Approves Merck and Astellas/Pfizer’s Bladder Cancer Combination Therapy

The MHRA has approved the combination of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) as a first-line treatment for metastatic urothelial carcinoma.

Merck & Co. (MSD outside the US and Canada) and Astellas/Pfizer’s collaboration has led to this important approval, specifically for adults with unresectable or metastatic urothelial carcinoma (UC) who are eligible for platinum-containing chemotherapy.

This decision follows promising results from the late-stage KEYNOTE-A39/EV-302 trial, which demonstrated a median overall survival of 31.5 months with the Keytruda-Padcev combination, compared to just 16.1 months for standard platinum-containing chemotherapy, indicating a 53% reduction in the risk of death. Additionally, the combination significantly improved progression-free survival, showing 12.5 months versus 6.3 months for chemotherapy.

With approximately 614,000 new bladder cancer diagnoses globally each year—90% of which are UC—this approval is particularly significant, as many patients present with advanced disease and poor survival outcomes.

Thomas Powles, primary investigator of the KEYNOTE-A39/EV-30 trial, highlighted the historic nature of this approval, stating, “The foundations of advanced bladder cancer treatment haven’t changed since the 1980s.” The swift transition from clinical trial to licensed indication reflects the strength of the trial results and their potential impact on patient care.

The Keytruda-Padcev combination has already received approval from the US FDA and European Commission for UC. Timir Patel, medical director at Astellas UK, emphasized the collaborative effort behind this achievement, expressing optimism for doctors in the UK to access these innovative treatment options for their patients.

This approval follows the recent MHRA endorsement of Astellas’ monoclonal antibody Vyloy (zolbetuximab) for a subset of gastric cancer patients, underscoring the rapid progress in cancer therapies.

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