FDA Approves Datroway®
On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (Datroway®, Daiichi Sankyo, Inc.) for the treatment of people with hormone receptor-positive (ER+ and/or PR+), HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) MBC who have received hormone therapy and chemotherapy. This approval is based on results from the phase III TROPION-Breast01 clinical trial.
Datopotamab deruxtecan-dlnk (Datroway®) for HR+, HER2- MBC
- US Food and Drug Administration: FDA approves datopotamab deruxtecan-dlnk (Datroway®) for HR-positive, HER2-negative MBC
- Breastcancer.org: Datopotamab deruxtecan-dlnk (Datroway®) is an antibody-drug conjugate
MBC Clinical Trials
- Metastatic Trial Search: Trials for datopotamab deruxtecan (Datroway®