Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
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: ...
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FDA Expands Label of AZN's Enhertu for New Breast Cancer IndicationAstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
New approval brings the medicine to an earlier treatment setting and a broader patient population.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the USA as the first HER2-directed ...
AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug ...
Several new treatment options for patients with breast cancer have emerged over the last few years, including more oral ...
FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...
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