The drug received priority review and breakthrough therapy designations for the indication, and approval was granted to Daiichi Sankyo four months ahead of the Prescription Drug User Fee Act deadline.
https://www.pharmalive.com/wp-content/uploads/2022/05/ReutersFDAlogo5-23-2022.webp7401200Administratorhttps://www.pharmalive.com/wp-content/uploads/2020/01/Pharmalive_4c-300x37.pngAdministrator2022-08-05 12:01:212022-08-05 12:01:21FDA Approves Enhertu, First Targeted Therapy for HER2-Low Breast Cancer