Merck: positive opinion for Keytruda in bladder cancer
(CercleFinance.com) - Merck today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, an antibody-drug conjugate for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
The recommendation is based on data from a Phase 3 trial conducted as part of a research collaboration with Pfizer and Astellas, in which Keytruda + enfortumab vedotin reduced the risk of death by 53% compared with platinum-based chemotherapy, and the risk of disease progression or death by 55%.
The CHMP recommendation will now be considered by the European Commission for marketing authorization in the European Union (EU), with a final decision expected in Q3 2024.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The recommendation is based on data from a Phase 3 trial conducted as part of a research collaboration with Pfizer and Astellas, in which Keytruda + enfortumab vedotin reduced the risk of death by 53% compared with platinum-based chemotherapy, and the risk of disease progression or death by 55%.
The CHMP recommendation will now be considered by the European Commission for marketing authorization in the European Union (EU), with a final decision expected in Q3 2024.
Copyright (c) 2024 CercleFinance.com. All rights reserved.