AstraZeneca, Daiichi Sankyo's Enhertu Combination Gets US Approval for Breast Cancer Treatment

11:23 PM EST, 12/15/2025 (MT Newswires) -- AstraZeneca (AZN.L, AZN.ST) and Daiichi Sankyo's Enhertu in combination with pertuzumab secured approval in the US as the first-line treatment of patients with unresectable or metastatic HER2-positive breast cancer, according to a Monday release. The approval followed the US Food and Drug Administration's breakthrough therapy designation and results from the Destiny-Breast09 phase 3 trial, which showed minimized disease progression or death risk by 44%, compared with taxane, trastuzumab, and pertuzumab. The safety profile was consistent with the known profiles of each therapy. The drug is currently under review by Swissmedic and Singapore's Health Sciences Authority, as well as other countries.