AstraZeneca的Enhertu獲美國優先審查，用於HER2陽性早期乳癌新輔助治療後
Enhertu若獲核准作為HER2陽性早期乳癌的新輔助治療後用藥，有望透過降低復發風險，顯著改善患者預後。
AstraZeneca的Enhertu因HER2陽性早期乳癌新輔助治療後之治療，獲得美國FDA優先審查，可能確立新的治療標準。
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若獲核准作為HER2陽性早期乳癌的新輔助治療後用藥，有望透過降低復發風險，顯著改善患者預後。這將確立新的治療標準，解決了初步治療後仍有殘留病灶患者的關鍵未滿足需求，並可能阻止疾病進展為轉移性乳癌。
Where this signal fits in the broader landscape.
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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