Astellas' Enfortumab Vedotin Approved in China for Locally Advanced or Metastatic Urothelial Cancer

Recently, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration has approved the use of Padcev (generic name: enfortumab vedotin for injection, hereinafter referred to as enfortumab vedotin) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who have previously received platinum-based chemotherapy and programmed death receptor-1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitor treatment.

Urothelial carcinoma is a serious and common cancer that affects the lower urinary tract (bladder and urethra) and upper urinary tract (ureter and renal pelvis). In 2022, China hadMore than 92,000 patients diagnosed with bladder cancer, and about 41,000 patients died.Patients with locally advanced or metastatic urothelial carcinomaThe survival rate is particularly low.MoreoverContinuous treatment and monitoring make bladder cancer one of the most expensive cancers to treat.

Vientamab is a direct-acting antibody targeting Nectin-4 (a protein located on the cell surface that is highly expressed in bladder cancer).A first-in-class antibody-drug conjugate (ADC).Non-clinical data show that vedotin exerts its anticancer activity by binding to cells expressing Nectin-4 protein, then internalizing and releasing the antitumor component monomethyl auristatin E (MMAE) into the cells, leading to cell cycle arrest and programmed cell death (apoptosis).

Vintafolide has been approved, providing another treatment option for patients with locally advanced or metastatic urothelial carcinoma in China, with the hope of achieving better treatment outcomes.

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