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.

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