T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.
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: ...
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 ...
In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine (T-DM1) reduced the long-term risk of death or invasive disease by 46% and ...
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 ...
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 addition of trastuzumab and pertuzumab to chemotherapy was associated with increased toxicity in patients with ...
Trastuzumab emtansine (T-DM1) demonstrates sustained improvement in invasive disease-free survival and reduced the risk for death in human epidermal growth factor receptor 2 (HER2)-positive breast ...
Adjuvant ado-trastuzumab emtansine significantly prolonged survival compared with trastuzumab for certain women with ...