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

If authorised by Japan’s Ministry of Health, Labour and Welfare, the combination would be the first non-chemotherapy treatment in the country for patients with locally advanced or metastatic urothelial cancer (la/mUC).

Padcev is a first-in-class antibody-drug conjugate that targets Nectin-4, a protein highly expressed in bladder cancer.

Astellas oncology development head and senior vice-president Ahsan Arozullah stated: “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 European Medicines Agency’s Committee for Medicinal Products for Human Use is currently reviewing the combination therapy, which received approval from the US Food and Drug Administration in December 2023.

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The sNDA is based on data from the Phase III EV-302 clinical trial, which demonstrated significant improvements in overall and progression-free survival for the Padcev and Keytruda combination compared to standard platinum-containing chemotherapy.

Also known as KEYNOTE-A39, the EV-302 trial is a pivotal study that enrolled 886 patients with previously untreated la/mUC.

The EV-103 trial is another ongoing study investigating enfortumab vedotin alone or along with pembrolizumab and/or chemotherapy in different settings of la/mUC and muscle-invasive bladder cancer (MIBC).

Two additional Phase III trials, EV-304 and EV-303, are examining the combination in MIBC.

The EV-202 trial is assessing enfortumab vedotin alone in advanced solid tumours and in combination with pembrolizumab in head and neck squamous cell carcinoma.