China's National Medical Products Administration (NMPA) approves Padcev (enfortumab vedotin) for treatment of locally advanced or metastatic urothelial cancer
Astellas Pharma Inc. announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved Padcev (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors
Urothelial cancer is a debilitating and often aggressive cancer that affects both the lower urinary tract (bladder and urethra) and upper urinary tract (ureter and renal pelvis). Over 92,000 people were diagnosed with bladder cancer in China in 2022, and approximately 41,000 deaths were reported as a result of the disease. Survival rates are particularly poor with locally advanced or metastatic urothelial cancer, driving the urgent need for new therapies that extend patients' lives.
Professor Guo Jun, Principal Investigator, EV-203 trial and Director of the Department of Melanoma and Urological Oncology, Beijing Cancer Hospital, China; "This approval, based on a global Phase III registration study as well as a bridging study in Chinese patients, is a milestone event where patients will now have access to this new antibody-drug conjugate (ADC) treatment in China".
The CDE's approval of enfortumab vedotin is supported by data from the global EV-301 and China EV-203 trials. EV-203 serves as a bridging trial to EV-301, a Phase III randomized trial that has supported global registrations of enfortumab vedotin.
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