datopotamab deruxtecan
Datroway · ATC code L01FX35
Also known as: Datopotamab derukstekan
- Key facts
- Active substance
- datopotamab deruxtecan
- ATC code
- L01FX35
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Datroway 100 mg powder for concentrate for solution for infusion
- Marketing authorisation holder
- Daiichi Sankyo Europe GmbH
- Information as of
- 2026-10-28
Key facts
Datopotamab deruxtecan (Datroway) is a TROP2-directed antibody-drug conjugate carrying a topoisomerase I inhibitor, given by infusion for certain advanced breast cancers.
What it is used for
- First-line treatment of unresectable or metastatic triple-negative breast cancer in adults who are not candidates for PD-1/PD-L1 inhibitor therapy.
- Unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer after endocrine therapy and at least one line of chemotherapy in the advanced setting.
Dosing
- 6 mg/kg body weight (up to a maximum of 540 mg for patients ≥90 kg) as an intravenous infusion every 3 weeks (21-day cycle) until progression or unacceptable toxicity.
- Dose reductions for adverse reactions: first to 4 mg/kg (maximum 360 mg), then 3 mg/kg (maximum 270 mg), then permanent discontinuation; no re-escalation.
- Premedication against infusion-related reactions (antihistamine, paracetamol, with or without glucocorticoids) should be considered before each infusion; prophylactic antiemetics are recommended.
- Prophylactic preservative-free lubricant eye drops and a daily steroid-containing mouthwash.
- No adjustment in mild hepatic impairment; limited data in moderate to severe hepatic impairment, use with caution.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Interstitial lung disease/pneumonitis, including fatal cases: cough, dyspnoea or fever should be reported immediately; permanently discontinue and give corticosteroids for symptomatic (Grade 2 or greater) cases.
- Keratitis and other ocular surface effects (dry eye, photophobia, vision changes); regular ophthalmic monitoring.
- Stomatitis including mouth ulcers; good oral hygiene and steroid-containing mouthwash.
- Infusion-related reactions and serious hypersensitivity; permanently discontinue for life-threatening reactions.
Side effects
- Very common: stomatitis (64.3%), nausea (52.7%), fatigue (40.4%), alopecia (36.9%), constipation (34.7%), vomiting (25.0%), dry eye (23.9%), anaemia (19.3%), keratitis (16.6%).
- Most common serious adverse reactions: pneumonia (1.9%), COVID-19 (1.5%), ILD/pneumonitis (1.1%) and vomiting (1.1%).
Interactions
- No clinical interaction studies have been conducted; CYP3A4 and OATP1B inhibitors are unlikely to have a clinically relevant effect on the released deruxtecan.
Pregnancy and breastfeeding
- Can cause foetal harm; not recommended in pregnancy. Women should use contraception for at least 7 months, and men with female partners of childbearing potential for at least 4 months, after the last dose.
- Breast-feeding should stop before treatment and may resume 1 month after treatment ends.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- DatrowayDaiichi Sankyo Europe GmbH · EMEA/H/C/006547
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Datroway
- Liechtenstein
- Datroway
- Norway
- Datroway
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Datroway – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.