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: ...
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 U.S. regulator has cleared Enhertu as the first HER2-directed treatment for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more ...
Enhertu reduced the risk of disease progression or death by 36%, with a median PFS of 13.2 months versus 8.1 months for chemotherapy. The trial showed an ORR of 62.6% for Enhertu compared to 34.4% ...
Trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a HER2-directed antibody-drug conjugate. The agent is approved in the United States for several indications, including treatment 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 ...
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