Datroway
Authorised
This medicine is authorised for use in the European Union
datopotamab deruxtecan
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Datroway is a cancer medicine used on its own in adults to treat breast cancer known as triple-negative breast cancer. In triple-negative breast cancer, the cancer cells do not have receptors (targets) for oestrogen and progesterone on their surface and do not make abnormally high levels of a protein called HER2 (HER2-negative). Datroway is used in patients who cannot receive medicines called PD-1/PD-L1 inhibitors, when their cancer cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic).
It is also used in patients whose cancer cells have targets for oestrogen and progesteroneon their surface (HR-positive) and are HER2-negative. It is used in patients who have had endocrine therapy (hormone treatment) as well as one additional cancer treatment, when their cancer is unresectable or metastatic.
Datroway contains the active substances datopotamab deruxtecan.
Datroway can only be obtained with a prescription by a doctor and is given under the supervision of a healthcare professional experienced in the use of cancer medicines.
Datroway is given by infusion (drip) into a vein. The dose depends on the patient’s weight and the infusion is repeated every 3 weeks. Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes. Patients may remain on treatment unless the disease gets worse or they no longer tolerate treatment.
Patients are monitored for any reactions during the infusion and for at least 30 minutes afterwards. Infusion-related reactions can be severe and, to reduce their risk, patients should be given other medicines before treatment with Datroway. If the patient develops infusion-related reactions, the doctor may slow down or stop the infusion.
For more information about using Datroway, see the package leaflet or contact your doctor or pharmacist.
The active substance in Datroway, datopotamab deruxtecan, is made up of two components that are linked together:
- datopotamab is a monoclonal antibody (a type of protein) that has been designed to target breast cancer cells in the body. It does this by attaching to a protein called TROP2 that is present at high levels on the surface of breast cancer cells;
- deruxtecan becomes active once datopotamab has attached to TROP2 and enters the cancer cell. Deruxtecan kills the cancer cell by blocking an enzyme (protein) called topoisomerase I which is involved in making new cancer cells.
In one main study involving 644 patients with unresectable and metastatic triple-negative breast cancer, Datroway was compared with standard chemotherapy treatment. Patients who received Datroway lived for a median time of 10.8 months without their disease worsening (progression-free survival), compared with 5.6 months for the patients who received standard treatment. Patients on Datroway lived for a median time (overall survival) of 23.7 months compared with 18.7 months for patients on chemotherapy treatment.
In another main study involving 732 patients with HR-positive, HER2-negative breast cancer that was metastatic or that could not be removed by surgery, Datroway was compared with chemotherapy chosen by the doctor for each patient. Patients had received at least one previous chemotherapy treatment. Patients given Datroway lived for a median time of 6.9 months before their disease got worse, compared with 4.9 months for patients given chemotherapy. Patients given Datroway lived for a median time of 18.6 months compared with 18.3 months for patients given chemotherapy.
Studies carried out with Datroway are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Datroway, see the package leaflet.
The most common side effects with Datroway (which may affect more than 1 in 10 people) include stomatitis (inflammation of the lining of the mouth), nausea (feeling sick), tiredness, alopecia (hair loss), constipation, vomiting, dry eye, keratitis (inflammation of the cornea), COVID-19, anaemia (low levels of red blood cells), decreased appetite, increase in liver enzymes called aspartate aminotransferase and alanine aminotransferase, rash, diarrhoea, leukopenia (low levels of white blood cells) and neutropenia (low levels of neutrophils, a type of white blood cell).
Some side effects can be serious. The most frequently reported serious side effects with Datroway (which may affect up to 1 in 10 people) include COVID-19, pneumonia (infection of the lungs), pneumonitis (inflammation in the lungs) and vomiting.
In patients with metastatic, unresectable triple negative breast cancer who cannot receive PD-1/PD-L1 inhibitors, Datroway has been shown to improve survival and to delay the progression of the disease compared to standard chemotherapy treatment.
For patients with HR-positive, HER2-negative metastatic breast cancer, despite recent medical advances, there remains a need for better treatments. Datroway has been shown to delay the progression of the disease compared to standard chemotherapy treatment, especially for patients who have already undergone multiple treatments. However, Datroway was not compared to two commonly used chemotherapy treatments which means that the real-life benefits might differ from those seen in the study. In terms of safety, Datroway can cause side effects affecting the gut, eyes, skin and other tissues. However, these can be managed using routine clinical practice guidelines.
The European Medicines Agency therefore decided that Datroway’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Datroway have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Datroway are continuously monitored. Suspected side effects reported with Datroway are carefully evaluated and any necessary action taken to protect patients.
Datroway received a marketing authorisation valid throughout the EU on 4 April 2025.
For information about the availability of this medicine in your country, contact your national competent authority.
Product information
Latest procedure affecting product information:VR/0000316654
29/07/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Datroway
- Active substance
- datopotamab deruxtecan
- International non-proprietary name (INN) or common name
- datopotamab deruxtecan
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01FX35
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Breast cancer
Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
News on Datroway
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