Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas")  announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company's Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA^® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The sNDA was submitted in January 2024. If approved, PADCEV with KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. 

Priority reviews are granted by MHLW for applications based on their clinical usefulness and the seriousness of the diseases for which they are indicated.ⁱ The sNDA for the first-line use of this combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found the combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. The safety results were consistent with those previously reported with this combination, and no new safety issues were identified. 

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas 
"The MHLW's priority review for our application for PADCEV in combination with pembrolizumab reflects the significance of the EV-302 trial findings and the urgent need for innovative new treatment options. We are pleased by this review designation and hope to quickly bring this treatment option to those who need it most."

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency is also reviewing the combination therapy. The U.S. Food and Drug Administration approved the combination therapy in December 2023.

Globally, approximately 614,000 new cases of bladder cancer and approximately 220,000 deaths are reported annually.ⁱⁱ It is estimated that approximately 25,000 people in Japan are diagnosed with bladder cancer each year and approximately 10,000 deaths were reported in 2022.ⁱⁱⁱ