BLA 761464, held by Daiichi Sankyo Inc. Datopotamab Deruxtecan-Dlnk.
As of Nov 13, 2026, BLA 761464 (Datroway), held by Daiichi Sankyo Inc, was first approved by FDA on Jun 23, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Datroway100MG · injectable;injection | 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
