Astellas seeks approval from Japan's MHLW for the combination therapy to treat adult patients with previously untreated locally advanced or metastatic urothelial cancer
Astellas Pharma’s Canada office. (Credit: Raysonho @ Open Grid Scheduler / Grid Engine from Wikimedia Commons)
Astellas Pharma has submitted a Supplemental New Drug Application (sNDA) in Japan for Padcev (enfortumab vedotin (genetical recombination)) with Keytruda (pembrolizumab (genetical recombination)) as a first line of treatment of advanced bladder cancer.
Astellas seeks approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the combination therapy to treat adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
If approved, Padcev with Keytruda will become the first combination therapy to offer an alternative to platinum-containing chemotherapy, the current standard of care.
Astellas senior vice president and oncology development head Ahsan Arozullah 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 for the first-line use of this combination was based on the outcomes of the Phase 3 EV-302 clinical trial, also known as KEYNOTE-A39.
In 886 patients with previously untreated la/mUC, the combination was observed to improve overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful effects when compared to platinum-containing treatment.
There were no new safety concerns found, and the safety results were in line with those that had previously been reported with this combination.
The combo medication is also being reviewed by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). It was accepted for review recently.
The therapy was approved by the US Food and Drug Administration in December 2023.