智通财经app获悉,1月27日,第一三共与阿斯利康(azn.us)宣布enhertu(德曲妥珠单抗)的补充生物制品许可申请(sbla)获fda批准,用于单药治疗在转移性 ...
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...
其中,第一三共的明星产品Enhertu(德曲妥珠单抗)在2024财年前三季度全球销售额为4044亿日元(约26.82亿美元)。经查询,Enhertu在2024年Q1(即2023年 ...
Enhertu (fam-trastuzumab deruxtecan-nxki) can cause side effects that range from mild to serious. More common side effects include hair loss, nausea, and vomiting. If Enhertu side effects become ...
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year Approval brings ...
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
The company’s PATHWAY HER2 antibody test—used to help screen patients for treatment with Enhertu (trastuzumab deruxtecan-nxki), the antibody-drug conjugate jointly developed by Daiichi Sankyo ...
Enhertu achieved a median progression-free survival of 13.2 months versus 8.1 months for chemotherapy, with a higher objective response rate of 62.6% compared to 34.4%. This summary was ...