US FDA Gives Quick Approval for First Low-HER2 Breast Cancer Drug

August 8, 2022

The US Food and Drug Administration (FDA) has approved Enhurtu, the first drug to treat metastatic or unresectable low-HER2 breast cancer, a recently defined category of the disease. The drug, developed by AstraZeneca and Daiichi Sankyo, received expedited approval from the agency, in part because of the potential for the breast cancer category, which covers over half of cases previously defined as HER2-negative.

According to Angus Liu, “In the groundbreaking Destiny-Breast04 trial, Enhertu cut the risk of disease progression or death by 50% and the risk of death by 36% over the physician’s choice of chemo in patients with previously treated HER2-low metastatic breast cancer. The drug showed similar benefits in both HR-negative and HR-positive patients, although the HR-negative population is rather small. Improvements in the lower boundary of HER2 expression—IHC 1+—were also consistent with those among higher expressers.”

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