Enhertu Granted Breakthrough Therapy Designation in the US

AstraZeneca PLC announced that Enhertu (trastuzumab deruxtecan) has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA). This designation is for the treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant treatment and are at high risk of recurrence. The BTD was based on positive results from the DESTINY-Breast05 Phase III trial, which demonstrated Enhertu's potential to reduce the risk of disease recurrence compared to the current standard of care. This marks the tenth BTD for Enhertu, highlighting its significant clinical benefit in various breast cancer settings. The DESTINY-Breast05 trial results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine. AstraZeneca and Daiichi Sankyo are collaborating on the development and commercialization of Enhertu, aiming to improve outcomes for patients with different subtypes of breast cancer.