Enhertu Gains Expanded FDA Approval for HER2-Low and Ultralow Breast Cancer Treatments

The Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu for expanded use in treating an aggressive form of breast cancer. This development positions the drug as a preferred option before chemotherapy in patients with low HER2-expressing tumors, marking a significant shift in cancer treatment paradigms.

Enhertu, an innovative antibody-drug conjugate (ADC), targets HER2-expressing tumor cells and has now been cleared by U.S. regulators for broader applications in breast, lung, and gastric cancers. Previously, Enhertu was reserved for patients whose disease had advanced despite hormone therapies and chemotherapy. The recent approval allows its use in patients with lower HER2 levels, reflecting the evolving understanding of HER2’s role in breast cancer. AstraZeneca estimates that up to two-thirds of hormone receptor-positive breast cancers, traditionally labeled as HER2-negative, actually have low HER2 expressions. This advance means a greater number of patients could benefit from this targeted therapy over conventional chemotherapy, potentially altering treatment standards.

Enhertu’s expanded FDA approval could transform clinical practice by offering a chemotherapy alternative for certain breast cancer patients. As AstraZeneca and Daiichi Sankyo continue their innovations, the medical community eagerly anticipates further proof of Enhertu’s efficacy in extending survival rates. This development underscores the critical importance of understanding HER2 status, providing hope and new treatment pathways for countless individuals battling breast cancer.

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