AstraZeneca’s Enhertu Gains FDA Approval in Two Early HER2-Positive Breast Cancer Settings
AstraZeneca and Daiichi Sankyo announced that the FDA approved Enhertu (trastuzumab deruxtecan) for two new indications in HER2-positive early breast cancer, expanding its use into both pre-surgery (neoadjuvant) and post-surgery (adjuvant) treatment settings. The approvals were based on positive Phase III DESTINY-Breast11 and DESTINY-Breast05 trial results, which showed improved outcomes for patients with high-risk or residual disease. These new indications move Enhertu further into curative-intent treatment and strengthen its position as a foundational therapy across multiple stages of HER2-positive breast cancer care. 
AstraZeneca’s Enhertu Gains FDA Approval in Two Early HER2-Positive Breast Cancer Settings