The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Astellas’ PADCEV (enfortumab vedotin), a new antibody-drug conjugate (ADC) to treat locally advanced or metastatic urothelial cancer. The ADC is intended for adult patients with locally advanced or metastatic urothelial cancer after previous treatment with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. The gold standard of business intelligence.
PADCEV targets Nectin-4, a protein highly expressed in bladder cancer. Its mechanism involves binding to cancer cells, internalising and then releasing a cytotoxic agent, leading to cell death. The latest approval is based on the results from the global EV-301 trial and the China-specific EV-203 trial, which served as a bridging study.
EV-203 is a single-arm, open-label, multicentre Phase II trial of enfortumab vedotin in patients with la/mUC who previously received a PD-1/PD-L1 inhibitor and platinum-based chemotherapy. The EV-203 trial demonstrated a statistically significant objective response rate of 37.5% in patients treated with PADCEV, with the majority of adverse events being low-grade.
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