Quick answers
- What is Datopotamab deruxtecan used for?
- The FDA-approved label (Datroway, Daiichi Sankyo Inc., May 27, 2026) says: “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 page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Datopotamab deruxtecan have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Datopotamab deruxtecan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Datopotamab deruxtecan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Datopotamab deruxtecan?
- 1 company lists prescription products of Datopotamab deruxtecan in the FDA NDC Directory, including Daiichi Sankyo Inc..
What Datopotamab deruxtecan is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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. …
— FDA label: Datroway, Daiichi Sankyo Inc., effective May 27, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Datroway |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Daiichi Sankyo Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761394 DATROWAY | Daiichi Sankyo Inc | January 17, 2025 | 1, latest May 22, 2026 2026: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2703040, 2703046 |
|---|---|
| SPL set ID of the quoted label | 2950227c-6230-4ca4-a135-46e44d9424a0 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761394 |
| Active ingredients (FDA) | DATOPOTAMAB DERUXTECAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Datroway, Daiichi Sankyo Inc., effective May 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →