Japanese regulator reviews first-line bladder cancer combination


Astellas has submitted a supplemental new drug application (sNDA) in Japan for Padcev (enfortumab vedotin (genetical recombination)) with Keytruda (pembrolizumab (genetical recombination)) for the first-line treatment of advanced bladder cancer.

If approved, it would be the first combination in Japan to offer an alternative to chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer.

Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually. 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.

Ahsan Arozullah, Senior Vice President, Head of Oncology Development, Astellas, said: “The initiation of MHLW’s review of our application for enfortumab vedotin and pembrolizumab is encouraging, as we are working to improve upon current treatment options for patients in Japan with advanced stage urothelial cancer, who face poor outcomes at the advanced stage. This submission brings us one step closer to the possibility of offering these patients a treatment that demonstrated improved survival and slowed disease progression compared to platinum-containing chemotherapy.”

The sNDA is based on results from the Phase III EV-302 clinical trial. 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.

The US Food and Drug Administration approved the combination therapy in December 2023. It is also under review with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

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