AstraZeneca's Enhertu Granted US Priority Review for HER2-Positive Early Breast Cancer Post-Neoadjuvant Treatment
Enhertu's potential approval as a post-neoadjuvant treatment for HER2-positive early breast cancer could significantly improve patient outcomes by reducing recurrence risk.
阿斯利康的Enhertu因HER2阳性早期乳腺癌新辅助治疗后治疗获得美国FDA优先审查，可能确立新的治疗标准。
AstraZeneca and Daiichi Sankyo's Enhertu has been granted Priority Review by the US FDA for treating adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant treatment. This is based on the DESTINY-Breast05 Phase III trial, where Enhertu showed a 53% reduction in the risk of invasive disease recurrence or death compared to trastuzumab emtansine (T-DM1). The FDA's decision is expected in the third quarter of 2026. If approved, Enhertu could become a new standard of care in this setting.
Enhertu's potential approval as a post-neoadjuvant treatment for HER2-positive early breast cancer could significantly improve patient outcomes by reducing recurrence risk. This would establish a new standard of care, addressing a critical unmet need for patients with residual disease after initial therapy and potentially preventing progression to metastatic disease.
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https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-granted-priority-review-in-the-us-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer.html
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