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 ...
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 ...
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 ...
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 ...
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 ...
Growth is expected to be supported by ENHERTU's continued expansion. Profit attributable to owners of the company for FY2024 was revised upward by ¥15 billion to ¥240 billion, driven by improved ...
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 ...
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 ...
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% ...
Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...