AZN :FDA Approves ENHERTU For HER2-Positive Early Breast Cancer In Neoadjuvant And Adjuvant Settings

India, May 17 -- The US Food and Drug Administration approved AstraZeneca (AZN) and Daiichi Sankyo's ENHERTU (fam-trastuzumab deruxtecan-nxki) 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 (THP) 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 (with or without pertuzumab) and...