FDA Approves ENHERTU for Breast Cancer

The United States — Food and Drug Administration has approved Trastuzumab deruxtecan, a drug jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, for two new indications in the treatment of HER2-positive early breast cancer. This approval covers both neoadjuvant and adjuvant settings, based on positive results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials. In the neoadjuvant setting, Trastuzumab deruxtecan followed by THP is approved for adult patients with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, Trastuzumab deruxtecan is approved for adult patients with HER2-positive breast cancer who have residual invasive disease after prior trastuzumab and taxane-based treatment. This expands Trastuzumab deruxtecan's existing approvals, which already include treatment for HER2-positive metastatic breast cancer in over 95 countries.