Drug Approval | May 25, 2026
Datroway wins US nod in aggressive breast cancer subtype
Clearance marks major shift beyond chemotherapy
Clearance marks major shift beyond chemotherapy
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
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