AstraZeneca, Daiichi Sankyo win FDA label expansion for Enhertu in HER2-low breast cancer
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The U.S. Food and Drug Administration (FDA) on Friday approved the cancer medication Enhertu, developed by AstraZeneca (NASDAQ:AZN) and its Japanese partner Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY), for adult patients with HER2-low breast cancer.
HER2 is a tyrosine kinase receptor growth-promoting protein detected in many tumor types, including breast cancer. About half of all breast cancer patients have tumors with low HER2 expression.

The FDA said todayâs decision permits the first authorized therapy for the HER2-low breast cancer subtype, a newly identified subset of HER2-negative breast cancer. Before the approval, endocrine therapy or chemotherapy was used to treat HER2-low patients. 
âHaving therapies that are specially tailored to each patientâs cancer subtype is a priority to ensure access to safe and innovative treatments,â noted the acting director of the Office of Oncologic Diseases in the FDAâs Center for Drug Evaluation and Research.
Last month, AstraZeneca (AZN) and Daiichi Sankyo (OTCPK:DSKYF) announced the FDAâs priority review for the label expansion of Enhertu, also known as trastuzumab deruxtecan. A decision on the supplemental biologics license application (sBLA) was expected in 4Q 2022.