European Commission Expands Keytruda-Padcev Use for Cisplatin-Eligible MIBC

The European Commission on Oct. 21 expanded EU approval of Merck’s Keytruda (pembrolizumab) and Astellas Pharma Inc.’s Padcev (enfortumab vedotin) for resectable muscle-invasive bladder cancer, adding patients who can receive cisplatin to the treatment population. The regimen begins before surgery and continues after radical cystectomy, an operation to remove the bladder. The earlier EU indication covered adults unable to receive cisplatin-based chemotherapy. The expansion applies across the 27 EU member states, as well as Iceland, Liechtenstein and Norway; availability in each country depends in part on reimbursement procedures.

Source: TokenPost