Astellas Pharma, Seagen: Japan’s MHLW Oks PADCEV For Advanced Urothelial Cancer

Japan’s Astellas Pharma Inc. (ALPMY,ALPMY) and Seagen Inc. (SGEN) announced Monday that PADCEV (enfortumab vedotin) has received approval from Japan’s Ministry of Health, Labour and Welfare or MHLW. The approval is for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review.

PADCEV is co-developed by Astellas and Seagen.

Radically unresectable urothelial carcinoma is urothelial cancer that cannot be treated by surgical removal of the urinary bladder or the kidney and the ureter due to tumor growth.

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

The latest approval is primarily based on the global Phase 3 EV-301 clinical trial, which included sites in Japan. The trial evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

At the time of pre-specified interim analysis, patients who received enfortumab vedotin in the trial lived a median of 3.9 months longer than those who received chemotherapy. Median overall survival was 12.9 vs. 9.0 months, respectively.

Andrew Krivoshik, Senior Vice President and Head of Development Therapeutic Areas, Astellas, said, “The MHLW’s review of enfortumab vedotin in just six months, supported by overall survival data from a pivotal Phase 3 clinical trial, reflects the seriousness of this condition and the potential benefit of enfortumab vedotin for patients in Japan.”

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