Treats locally advanced or metastatic epidermal growth factor … lung cancer (NSCLC). BLA 761394, held by Daiichi Sankyo Inc. Datopotamab Deruxtecan-Dlnk.
As of Nov 13, 2026, BLA 761394 (Datroway), held by Daiichi Sankyo Inc, was first approved by FDA on Jan 17, 2025, with 1 approved supplement and 0 published complete response letters.
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. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2026 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jan 17, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Datroway100MG · injectable; iv (infusion) | Datopotamab Deruxtecan-Dlnk | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
