The European Commission granted Marketing Authorization for Padcev (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy in the European Union.
FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
