AstraZeneca, Daiichi Sankyo's Breast Cancer Drug Granted Breakthrough Therapy Status in US

02:53 AM EST, 12/22/2025 (MT Newswires) -- AstraZeneca (AZN.L, AZN.ST) and Daiichi Sankyo's Enhertu received the US Food and Drug Administration's breakthrough therapy designation for early breast cancer. The designation is for treating adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant therapy and a high risk of disease recurrence, according to a Monday release. The US FDA's decision, which marks the 10th breakthrough therapy designation for Enhertu, is supported by data from the late-stage Destiny-Breast05 trial.