Daiichi Sankyo, AstraZeneca’s Enhertu approved by U.S. FDA

AstraZeneca (AZN) and Daiichi Sankyo’s (DSNKY) Enhertu has been approved by the US Food and Drug Administration, FDA, for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively. In the neoadjuvant setting, Enhertu followed by a taxane, trastuzumab, and pertuzumab has been approved for the treatment of adult patients with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, Enhertu has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab and taxane-based treatment.