Datopotamab deruxtecan is a prescription medicine indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), among other approved uses. MedsAcross supplies Datopotamab deruxtecan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death. Datopotamab deruxtecan-dlnk had anti-tumor activity in mouse models of lung cancer including EGFR-mutated and breast cancer.
Source: US FDA prescribing information
Reconstitute DATROWAY with Sterile Water for Injection. Dilute with 5% Dextrose Injection. For intravenous infusion only. Do not administer as an intravenous push or bolus. DO NOT use Sodium Chloride Injection, USP. Premedicate to reduce the risk of infusion reactions and nausea and vomiting. The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Interstitial Lung Disease (ILD) and Pneumonitis: DATROWAY can cause severe and fatal cases of ILD/pneumonitis. Monitor for new or worsening signs and symptoms of ILD/pneumonitis. If ILD/pneumonitis is suspected, withhold DATROWAY and initiate corticosteroids. Permanently discontinue DATROWAY in patients with confirmed Grade 2 or higher ILD/pneumonitis. Ocular Adverse Reactions: DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. Monitor patients for ocular adverse reactions during treatment with DATROWAY. Advise patients to use preservative-free lubricating eye drops and to avoid using contact lenses during treatment with DATROWAY. Withhold, reduce the dose, or permanently discontinue DATROWAY based on the severity of ocular adverse reactions.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis Ocular Adverse Reactions Stomatitis The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash.
Source: US FDA prescribing information
Do not freeze. Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not shake the reconstituted or diluted solution.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Datopotamab deruxtecan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Datroway 100 mg/5 mL powder for injectionIntravenous Cold chain | Daiichi Sankyo | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Datopotamab deruxtecan and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Datopotamab deruxtecan, including Datroway.
Yes. The US FDA first approved Datopotamab deruxtecan on 17 January 2025, according to Drugs@FDA.
Yes. Datopotamab deruxtecan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Datopotamab deruxtecan must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Datopotamab deruxtecan is classified under ATC code L01FX35 (Datopotamab deruxtecan).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.