AstraZeneca's Enhertu wins US approval for broader breast cancer use
AstraZeneca and Daiichi Sankyo have secured faster-than-expected U.S. approval for their drug, Enhertu, in patients with a particular form of breast cancer.
This is the first-ever U.S. Food and Drug Administration (FDA) approval for a medicine specifically targeting patients with so-called HER2-low breast cancer.
Breast cancer can express, at varying levels, a protein called HER2 that contributes to its growth and spread. HER2-low tumours are defined as those whose cells contain lower levels of the HER2 protein on their surface.
The U.S. approval is based on a data from a late-stage trial involving over 550 patients with HER2-low breast cancer - most with tumours that were hormone-sensitive - whose disease had spread and who had undergone at least one round of chemotherapy.