FDA 对阿斯利康-第一三共的 Enhertu 治疗晚期 HER2 阳性实体瘤给予优先审查，可能于 2024 年第二季度获得批准。 FDA grants Priority Review to AstraZeneca-Daiichi Sankyo's Enhertu for treating advanced HER2-positive solid tumors, with potential approval in Q2 2024.
阿斯利康和第一三共的 Enhertu（曲妥珠单抗 deruxtecan）已获得美国食品和药物管理局（FDA）的优先审查，用于治疗晚期 HER2 阳性实体瘤成人患者。 AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has received Priority Review from the US Food and Drug Administration (FDA) for the treatment of adult patients with advanced HER2-positive solid tumors. sBLA 提交是基于 DESTINY-PanTumor02 II 期试验和 Enhertu 临床开发计划中其他支持试验的数据。 The sBLA submission is based on data from the DESTINY-PanTumor02 Phase II trial and other supporting trials in the Enhertu clinical development program. 如果获得批准，Enhertu 可能成为第一个针对 HER2 的疗法和具有肿瘤不可知适应症的抗体药物偶联物，为患者提供潜在的新治疗选择。 If approved, Enhertu could be the first HER2-directed therapy and antibody drug conjugate with a tumor-agnostic indication, providing patients with a potential new treatment option. FDA 的决定行动日期是 2024 年第二季度。 The FDA action date for their decision is the second quarter of 2024.