The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...
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: ...
The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...
Women with high-risk HER2-positive breast cancer lived significantly longer with adjuvant trastuzumab emtansine (T-DM1, ...
Patients with HER-2 positive early breast cancer with residual invasive disease after neoadjuvant therapy were randomly ...
In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine ...
Trastuzumab, tested only as a single agent, has been shown to achieve 7% response in heavily pretreated patients with AOC with 3+ and 2+ HER2 immunostaining by immunohistochemistry (IHC).
The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with ...
The addition of trastuzumab and pertuzumab to chemotherapy was associated with increased toxicity in patients with ...
Adjuvant ado-trastuzumab emtansine significantly prolonged survival compared with trastuzumab for certain women with ...