- 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.
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