Policy & Regulation
Astellas Pharma receives Japanese regulator priority review approval for enfortumab vedotin New Drug Application
14 May 2021 -

Japan-based Astellas Pharma Inc (TSE: 4503) announced on Thursday that Japan's Ministry of Health, Labour and Welfare has given priority review for the firm's New Drug Application (NDA) for enfortumab vedotin.

The NDA was submitted in March. If the product receives approval, then it will be the first antibody-drug conjugate offered in Japan for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication.

Priority reviews are granted based on the product's clinical usefulness and the seriousness of the diseases for which they are indicated. The NDA includes data from the phase three EV-301 trial and the phase two EV-201 trial, both global clinical trials with investigational sites in Japan.

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