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 ...
Enhertu is approved for HR-positive, HER2-low or -ultralow metastatic breast cancer after endocrine therapy progression, based on DESTINY-Breast06 trial results. Enhertu showed a 36% reduction in ...
Dr. Debu Tripathy discusses the FDA approval of Enhertu in unresectable or metastatic hormone receptor HR+, HER2-low or -ultralow breast cancer. On Jan. 27, the Food and Drug Administration (FDA) ...
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 ...
In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA) has ...
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 ...
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 ...
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer. The FDA has approved ...
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