FDA Expands Use of T-DXd in Early HER2+ Breast Cancer
The FDA has approved expanded use of trastuzumab deruxtecan (T-DXd) for patients with HER2-positive early breast cancer. This includes new indications for both neoadjuvant and adjuvant treatment settings. The approval is based on positive results from two phase 3 clinical trials, which showed significant benefits in patient outcomes.
- ▪T-DXd is now approved for neoadjuvant treatment in adults with HER2-positive stage II or III breast cancer.
- ▪In the adjuvant setting, the drug is approved for patients with residual invasive disease after neoadjuvant therapy.
- ▪The expanded indications are supported by results from the DESTINY-Breast11 and DESTINY-Breast05 trials.
Opening excerpt (first ~120 words) tap to expand
The FDA has approved two new indications for trastuzumab deruxtecan (T-DXd; Enhertu, AstraZeneca/Daiichi Sankyo), broadening the drug’s use for patients with HER2-positive early breast cancer and moving the therapy into potentially curative treatment settings. The expanded indications for the anti-HER2 antibody-drug conjugate cover both the neoadjuvant and adjuvant settings. In the neoadjuvant setting, T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP) is now approved for adults with HER2-positive (immunohistochemistry [IHC] 3+ or in situ hybridization [ISH]+) stage II or III breast cancer.
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