The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.

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: ...

Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...

The FDA approves AstraZeneca's sBLA for Enhertu to treat HER2-low or HER2-ultralow metastatic breast cancer in the United ...

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...

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Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult ...

Updated results from the KATHERINE trial showed that adjuvant T-DM1 provided a significant improvement in overall survival and no evidence of long-term safety issues.