← All approvals · Cancer · 2025
Datroway (datopotamab deruxtecan-dlnk)
The FDA approved Datroway (datopotamab deruxtecan-dlnk) on January 17, 2025 to treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
- Brand name
- Datroway
- Generic name
- datopotamab deruxtecan-dlnk
- FDA approval date
- January 17, 2025
- Approved use (FDA wording)
- To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease
- Company
- Daiichi Sankyo Inc.
- Application
- BLA761394
- Dosage form / route
- INJECTABLE · IV (INFUSION)
- Boxed warning on label
- Not listed
- Category on this site
- Cancer
Indications and usage, from the FDA label
DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) wh…