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 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.