The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
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: ...
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug ...
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, ...
AstraZeneca (AZN) and Daiichi Sankyo’s ENHERTU has been approved in the US for the treatment of adult patients with unresectable or metastatic ...
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult ...