EU Medicines Agency Panel Backs Indication Extension for AstraZeneca, Daiichi Sankyo's Breast Cancer Drug

09:48 AM EDT, 09/18/2026 (MT Newswires) -- The European Medicines Agency's Committee for Medicinal Products for Human Use recommended an indication extension for AstraZeneca (AZN.L, AZN.ST) and Daiichi Sankyo's breast cancer drug Enhertu. The panel recommended Enhertu, or trastuzumab deruxtecan, for approval as a monotherapy for the adjuvant treatment of patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer, AstraZeneca said Friday. The recommendation follows positive results from the Destiny-Breast05 phase 3 trial, where Enhertu reduced the risk of invasive disease recurrence or death by 53%, compared with trastuzumab emtansine. Enhertu's safety profile was in line with its known profile, with no new safety concerns identified.