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European Medicines Agency accepts MAA for enfortumab vedotin to treat locally advanced or metastatic urothelial cancer. -Astellas + Seagen

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Published:27th Mar 2021
Astellas Pharma Inc. and Seagen Inc. announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA). The MAA requests review of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in the European Union for people living with urothelial cancer. Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation. The MAA is based on the global phase III EV-301 trial, which 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. Results from the trial, which had a primary endpoint of overall survival for patients treated with PADCEV versus chemotherapy, were published in the New England Journal of Medicine. “In the European Union, it is estimated that 118,000 people are diagnosed with urothelial cancer each year, and 52,000 die as a result of the disease,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. See-"Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma"-Thomas Powles, M.D., Jonathan E. Rosenberg, M.D., Guru P. Sonpavde, M.D., Yohann Loriot, M.D., Ph.D., , et al.-March 25, 2021N Engl J Med 2021; 384:1125-1135 , DOI: 10.1056/NEJMoa2035807.
Condition: Bladder Cancer
Type: drug

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