美国食品和药物管理局批准Enhertu用于早期HER2+乳腺癌后新辅助治疗,显示生存率有所改善. FDA approves Enhertu for early HER2+ breast cancer post-neoadjuvant therapy, showing improved survival.

FDA已授予Enhertu（曲妥珠单抗deruxtecan）突破性治疗资格，用于新辅助治疗后针对HER2阳性早期乳腺癌患者及其残留病灶，基于第三期DESTINY-Breast05试验结果，该试验显示与Kadcyla相比显著改善的无创疾病生存率。 The FDA has granted Breakthrough Therapy Designation to Enhertu (trastuzumab deruxtecan) for post-neoadjuvant treatment of HER2-positive early breast cancer patients with residual disease after neoadjuvant therapy, based on Phase 3 DESTINY-Breast05 trial results showing significantly improved invasive disease-free survival compared to Kadcyla. 在三年后,Enhertu患者的iDFS为91. 8%,而Kadcyla患者的83. 2%,HER2 IHC 3+患者的96. 2%,而HER2 ISH+患者的86. 5%. At three years, iDFS was 91.8% with Enhertu versus 83.2% with Kadcyla in HER2 IHC 3+ patients, and 96.2% versus 86.5% in HER2 ISH+ patients. 不同种类的化疗的好处是一致的。 Benefits were consistent across chemotherapy types. 9.6%的Enhertu患者患间歇性肺病,需要仔细监测。 Interstitial lung disease occurred in 9.6% of Enhertu patients, requiring careful monitoring. 该药物已在90多个国家获得批准,于2024年在全球销售额中已产生37.5亿美元,现已进入治疗内脏癌的第三阶段试验阶段。 The drug, already approved in over 90 countries, has generated $3.75 billion in global sales in 2024 and is now in a Phase 3 trial for endometrial cancer.