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: ...

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

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 ...

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

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.

SAN DIEGO — The true incidence of thrombosis among people who received targeted therapy for breast cancer is significantly higher than reported in prior clinical trials, according to study results.

And, in fact, this study showed that the additional palbociclib to this kind of treatment was able to significantly prolong ...

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