Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
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 (see section 5.1).
Datroway should be prescribed by a physician and administered under the supervision of a healthcare professional experienced in the use of anticancer medicinal products.
Patients for treatment of unresectable or metastatic HR-positive, HER2-negative breast cancer should be selected on the basis of a documented HER2-negative result assessed by a CE marked IVD if available, or an alternative validated test.
The recommended dose of Datroway is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) of body weight given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
Prior to each infusion of Datroway, a premedication regimen for the prevention of infusion-related reactions that consists of an antihistamine and paracetamol (with or without glucocorticoids) should be considered (see section 4.8).
It is also recommended that patients receive prophylactic antiemetic agents (dexamethasone with 5-HT3 antagonists as well as other medicinal products, such as NK1 receptor antagonists) prior to infusion of Datroway and on subsequent days as needed.
For prophylactic treatment for keratitis and stomatitis, see section 4.4.
The infusion rate of Datroway should be slowed or interrupted if the patient develops an infusion-related reaction. Datroway should be permanently discontinued in case of life-threatening infusion-related reactions.
Management of adverse reactions may require dose delay, dose reduction, or treatment discontinuation per guidelines provided in Tables 1 and 2.
Datroway dose should not be re-escalated after a dose reduction is made.
Table 1. Dose reductions for adverse reactions:
| Recommended starting dose | 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) |
| First dose reduction | 4 mg/kg (up to a maximum of 360 mg for patients ≥90 kg) |
| Second dose reduction | 3 mg/kg (up to a maximum of 270 mg for patients ≥90 kg) |
Table 2. Dose modifications for adverse reactions:
| Adverse reaction | Severity* | Dose modification |
|---|---|---|
| Interstitial lung disease (ILD)/pneumonitis [see sections 4.4 and 4.8] | Asymptomatic ILD/pneumonitis (Grade 1) | Delay dose until resolved to Grade 0#, then: • if resolved in 28 days or less from date of onset, maintain dose. • if resolved in greater than 28 days from date of onset, reduce dose one level (see Table 1). • consider corticosteroid treatment as soon as ILD/pneumonitis is suspected. |
| Symptomatic ILD/pneumonitis (Grade 2 or greater) | • Permanently discontinue. • Promptly initiate corticosteroid treatment as soon as ILD/pneumonitis is suspected. | |
| Keratitis [see sections 4.4 and 4.8] | Grade 2 | • Delay dose until resolved to Grade 1 or less, then maintain dose. |
| Grade 3 | • Delay dose until resolved to Grade 1 or less, then reduce the dose by 1 level (see Table 1). | |
| Grade 4 | • Permanently discontinue. | |
| Stomatitis [see sections 4.4 and 4.8] | Grade 2 | • Delay dose until resolved to Grade 1 or less. • Restart at the same dose for first occurrence. • Consider restarting at reduced dose level (see Table 1) if recurrent. |
| Grade 3 | • Delay dose until resolved to Grade 1 or less. • Restart at reduced dose level (see Table 1). | |
| Grade 4 | • Permanently discontinue. |
* Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
# Grade 0 refers to full resolution of ILD/pneumonitis, including the disappearance of radiological findings associated with active ILD/pneumonitis. Residual scarring or fibrosis following recovery of ILD/pneumonitis is not considered to be active disease.
If a planned dose is delayed or missed, it should be administered as soon as possible without waiting until the next planned cycle. The schedule of administration should be adjusted to maintain a 3-week interval between doses.
No dose adjustment of Datroway is required in patients aged 65 years or older. Data from datopotamab deruxtecan in patients aged 85 years or older are limited.
No dose adjustment is required in patients with mild to moderate (creatinine clearance [CLcr] ≥30 and <90 mL/min) renal impairment (see section 5.2). The recommended dosage of Datroway has not been established in patients with severe renal impairment (see section 5.2). Patients with severe renal impairment should be monitored carefully. In patients with moderate renal impairment at baseline who received datopotamab deruxtecan 6 mg/kg, a higher incidence of serious adverse reactions was observed compared to those with normal renal function.
No dose adjustment is required in patients with mild (total bilirubin ≤ upper limit of normal (ULN) and any aspartate aminotransferase (AST) > ULN or total bilirubin >1 to 1.5 times ULN and any AST) hepatic impairment. There are limited data to make a recommendation on dose adjustment in patients with moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment. Insufficient data are available in patients with severe (total bilirubin >3 times ULN and any AST) hepatic impairment. Therefore, patients with moderate and severe hepatic impairment should be monitored carefully (see section 4.4 and 5.2).
The safety and efficacy in children and adolescents below 18 years of age have not been established. No data are available.
Datroway is for intravenous use. It must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion. Datroway must not be administered as an intravenous push or bolus.
The first infusion is to be administered over 90 minutes. Patients should be observed during the infusion and for at least 30 minutes following the initial dose for signs or symptoms of infusion-related reactions.
Subsequent infusions are to be administered over 30 minutes if prior infusions were tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
This medicinal product contains a cytotoxic component, which is covalently attached to the monoclonal antibody (see special handling and disposal procedures in section 6.6).
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
There is currently no specific treatment in the event of an overdose. Higher than the indicated dosing may increase risk of adverse reactions. Physicians should follow general supportive measures and institute appropriate treatment.
Unopened vial:
3 years.
Reconstituted solution:
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Diluted solution:
It is recommended that the diluted solution be used immediately. If not used immediately, the diluted solution may be stored at room temperature (≤25°C) for up to 4 hours or in a refrigerator at 2°C to 8°C for up to 24 hours, protected from light.
The maximum time from reconstitution of the vial through the end of administration should not exceed 24 hours. Discard if storage time exceeds these limits.
Store in a refrigerator (2°C–8°C).
Do not freeze.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Datroway is provided in a 10 mL Type 1 amber borosilicate glass vial sealed with a fluoro-resin laminated butyl rubber stopper, and a polypropylene/aluminium blue flip-off crimp cap.
Each carton contains 1 vial.
Datroway contains a cytotoxic component and should be administered under the supervision of a physician experienced in the use of cytotoxic agents. Appropriate procedures for proper preparation, handling and disposal of antineoplastic and cytotoxic medicinal products should be used.
Appropriate aseptic technique should be used for the following reconstitution and dilution procedures.
Reconstitution:
Dilution:
Administration:
Disposal:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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