Japan’s MHLW grants priority review for PADCEV and KEYTRUDA combo in urothelial cancer

In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded priority review status to its Supplemental New Drug Application (sNDA) for PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for adults with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). This milestone, achieved in January 2024, signals a potential paradigm shift in cancer care, away from platinum-containing chemotherapy, the current standard of care.

Priority review in Japan is reserved for treatments that demonstrate significant clinical usefulness and address the urgent needs of serious diseases. The sNDA for PADCEV and KEYTRUDA is supported by compelling data from the Phase 3 EV-302 clinical trial, also known as KEYNOTE-A39. This study showcased the combination’s ability to significantly improve overall survival (OS) and progression-free survival (PFS), marking a notable advancement in the treatment of la/mUC. Importantly, the safety profile of this combination therapy has been consistent with prior findings, with no new safety concerns identified.

Ahsan Arozullah, Senior Vice President and Head of Oncology Development at Astellas, emphasized the importance of the MHLW’s decision, stating, “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 global impact of bladder cancer, with approximately 614,000 new cases and 220,000 deaths annually, underscores the critical need for new treatment options. In Japan alone, around 25,000 people are diagnosed with bladder cancer each year, with approximately 10,000 deaths reported in 2022. The EV-302 trial represents a key component of an extensive clinical program exploring this combination therapy across various stages of urothelial cancer and other solid tumors.

The combination therapy has also garnered attention outside Japan, with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) currently reviewing it, and the U.S. Food and Drug Administration having approved it in December 2023.

The priority review of Astellas Pharma’s PADCEV and KEYTRUDA combination by Japan’s MHLW is a beacon of hope for patients with urothelial cancer. This development not only highlights the innovative strides being made in oncology treatment but also emphasizes the global healthcare community’s commitment to advancing cancer care. With its potential to offer an effective alternative to traditional chemotherapy, this combination therapy could significantly improve the quality of life and outcomes for patients facing this challenging diagnosis.

PADCEV was developed by Astellas Pharma in collaboration with Seagen Inc. (formerly known as Seattle Genetics). This partnership combined Astellas’ expertise in developing novel cancer therapies with Seagen’s experience in antibody-drug conjugate (ADC) technology. PADCEV is a targeted cancer therapy designed for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received other treatments.

KEYTRUDA was developed by Merck & Co., Inc., known as MSD outside the United States and Canada. It is a type of immunotherapy that works by blocking the PD-1 (Programmed Death receptor-1) pathway, thereby enhancing the immune system’s ability to fight cancer cells. KEYTRUDA has been approved for the treatment of various types of cancer, including melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and urothelial carcinoma, among others. It has become a cornerstone in the field of oncology for its broad application in treating different cancers through immunotherapy.