EC approves PADCEV combination for first-line treatment of advanced urothelial cancer

KENILWORTH (NJ) (dpa-AFX) – Astellas Pharma Inc. (ALPMY, ALPMY) announced that the European Commission has granted marketing authorization for PADCEV (enfortumab vedotin, an antibody-drug conjugate (ADC)) in combination with KEYTRUDA (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are candidates for platinum-containing chemotherapy.

The approval was based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39), which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival and significantly extended progression-free survival (PFS) compared with platinum-containing chemotherapy.

The approval follows the December 2023 approval of enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer, or la/mUC, by the U.S. Food and Drug Administration (FDA), and the European Commission approval of enfortumab vedotin as monotherapy for the treatment of adult patients with la/mUC who have previously received platinum-based chemotherapy and a programmed death receptor-1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitor in April 2022.

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