Japan’s MHLW Approves PADCEV (enfortumab vedotin) for Advanced Urothelial Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review.

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.

“Unfortunately, advanced urothelial cancer has a relatively poor prognosis and can be challenging to treat with currently available therapies,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Head of Development Therapeutic Areas, Astellas. “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.”

The 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 (n=301) in the trial 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 [Hazard Ratio=0.70 (95% Confidence Interval [CI]: 0.56, 0.89), p=0.001]. The most common (≥20%) adverse reactions included alopecia, peripheral sensory neuropathy, pruritus, fatigue, decreased appetite, diarrhea, dysgeusia and nausea.

Each year in Japan, more than 24,300 people are diagnosed with bladder cancer and an estimated 9,500 die from the disease.¹ Enfortumab vedotin is the subject of a robust clinical development program aimed at addressing unmet needs across the continuum of urothelial cancer and in other solid tumors.

About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases), and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra. Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually.²