Datopotamab Deruxtecan Earns New Breast Cancer Indication
The FDA has approved datopotamab deruxtecan for treating patients with unresectable or metastatic triple-negative breast cancer. This approval is based on positive results from the TROPION-Breast02 trial, which demonstrated significant improvements in progression-free and overall survival compared to traditional chemotherapy. The treatment offers a new option for patients who are not candidates for immunotherapy.
- ▪Datopotamab deruxtecan is approved for patients with unresectable or metastatic triple-negative breast cancer who cannot receive PD-1 or PD-L1 inhibitors.
- ▪The approval follows a priority review and is based on the TROPION-Breast02 trial involving 644 patients.
- ▪The trial showed that median progression-free survival with Dato-DXd was 10.8 months compared to 5.6 months with chemotherapy.
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The FDA has approved datopotamab deruxtecan (Dato-DXd, Datroway, Daiichi Sankyo) for the treatment of patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.The approval marks the second breast cancer indication in the US for the Trop-2-directed antibody and topoisomerase inhibitor conjugate. The agent, which also has lung cancer indications, was first approved for breast cancer in January 2025 for previously treated patients with unresectable or metastatic HR-positive, HER2-negative disease.
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