林业发展局将优先审查HER2+转移性乳腺癌的Enhertu组合疗法,预计2026年1月23日作出决定。 FDA grants priority review to Enhertu combo therapy for HER2+ metastatic breast cancer, with decision expected Jan 23, 2026.

美国林业发展局给予Enhertu优先审查权,这是AstraZeneca和Daichi Sankyo与Roche的pertuzumab的混合疗法,用于一线治疗HER2-呈阳性的转移性乳腺癌。 The U.S. FDA has granted priority review to Enhertu, a combination therapy by AstraZeneca and Daiichi Sankyo with Roche’s pertuzumab, for first-line treatment of HER2-positive metastatic breast cancer. 根据第3阶段试验结果,预计到2026年1月23日,将作出显示疾病增加或死亡减少44%的决定。 The decision, based on phase 3 trial results showing a 44% reduction in disease progression or death, is expected by January 23, 2026. 治疗以前曾被指定为突破性治疗,目前正在加速方案下进行审查。 The therapy previously received breakthrough therapy designation and is being reviewed under expedited programs. 如果获得批准,这将是第一线治疗的一大进步,这是十多年来的第一个。 If approved, it would represent a major advancement in first-line treatment, the first in over a decade. Enhertu已被超过85个国家批准用于后线用途。 Enhertu is already approved in over 85 countries for later-line use.