The U.S. Food and Drug Administration (FDA) has granted Daiichi Sankyo and AstraZeneca's Datroway (datopotamab deruxtecan-dlnk) a new indication for the treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD‑1/PD-L1 inhibitor therapy.
The expanded approval is based on results from the phase III TROPION‑Breast02 trial, which demonstrated statistically significant and clinically meaningful improvements in overall survival and a reduction in the risk of disease progression or death versus chemotherapy when used as first‑line treatment in this population.
Datroway is now FDA‑approved for both HR‑positive, HER2‑negative metastatic breast cancer and advanced triple‑negative breast cancer, making it an important new option for patients with limited treatment options.
Sources:
DATROWAY® (datopotamab deruxtecand-lnk) | HCP Website
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