FDA授予Enhertu和Pertuzumab联合疗法突破性疗法认定，用于一线治疗HER2阳性乳腺癌-动脉网

FDA Grants Breakthrough Therapy Designation to Enhertu and Pertuzumab Combination for First-Line Treatment of HER2-Positive Breast Cancer

GeneOnline 等信源发布 2025-07-18 21:06

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by Mark Chiang

由马克·蒋

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Daiichi Sankyo and AstraZeneca have announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to their jointly developed drug, Enhertu. The designation applies to the use of Enhertu in combination with pertuzumab as a first-line treatment for adult patients diagnosed with unresectable or metastatic HER2-positive breast cancer..

第一三共和阿斯利康宣布，美国食品药品监督管理局（FDA）已授予双方共同开发的药物Enhertu突破性疗法认定。该认定适用于Enhertu与帕妥珠单抗联合使用，作为不可切除或转移性HER2阳性乳腺癌成年患者的一线治疗方案。

The FDA’s decision highlights the potential of this combination therapy to address an unmet medical need in treating advanced stages of HER2-positive breast cancer, a condition characterized by aggressive tumor growth due to overexpression of the HER2 protein. This designation is intended to expedite the development and review process for therapies that show significant promise in early clinical evidence compared to existing treatments..

FDA的决定突显了这种联合疗法在治疗HER2阳性乳腺癌晚期阶段中满足未被满足的医疗需求的潜力，该病症因HER2蛋白过度表达而导致肿瘤生长迅速。这一指定旨在加速那些在早期临床证据中显示出较现有疗法显著优势的疗法的开发和审查过程。

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