Benzinga | Sep 27, 2021 10:35AM EDT

Astellas Pharma's Bladder Cancer Treatment Scores Approval In Japan

* Japan's Ministry of Health, Labor, and Welfare (MHLW) has approved Astellas Pharma Inc's (OTC: ALPMF) Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy.

* Enfortumab vedotin is the first and only antibody-drug conjugate approved in Japan for patients with advanced urothelial cancer.

* The approval is primarily based on the global Phase 3 EV-301 clinical trial.

* At the time of pre-specified interim analysis, patients who received enfortumab vedotin (n=301) lived a median of 3.9 months longer than those who received chemotherapy (n=307).

* Median overall survival was 12.9 vs. 9.0 months, respectively.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: ALPMF stock is down 1.67% at 16.86 during the market session on the last check Monday.