China approval for Astellas’ Padcev

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.

Padcev was developed by Japanese drugmaker Astellas Pharma (TYO: 4503) in partnership USA-based Seagen, which was acquired by Pfizer (NYSE: PFE) for $43 billion last year.

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