Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
Datroway 100 mg powder for concentrate for solution for infusion.
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Powder for concentrate for solution for infusion. White to yellowish white lyophilised powder, which has a cake-like appearance. |
One vial of powder for concentrate for solution for infusion contains 100 mg of datopotamab deruxtecan. After reconstitution, one vial of 5 mL solution contains 20 mg/mL of datopotamab deruxtecan (see section 6.6).
Datopotamab deruxtecan is an antibody-drug conjugate (ADC) that contains a humanised anti-TROP2 IgG1 monoclonal antibody (mAb) produced by mammalian (Chinese Hamster Ovary) cells, covalently linked to DXd, an exatecan derivative and a topoisomerase I inhibitor, via a tetrapeptide-based cleavable linker. Approximately 4 molecules of deruxtecan are attached to each antibody molecule.
Excipient with known effect: Each 100 mg vial contains 1.50 mg of polysorbate 80 (E433).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate. The antibody is a humanised anti-TROP2 IgG1 attached to deruxtecan, a topoisomerase I inhibitor (DXd) bound by a tetrapeptide-based cleavable linker. The antibody-drug conjugate is stable in plasma. The antibody binds to TROP2 expressed on the surface of certain tumour cells. After binding, datopotamab deruxtecan undergoes internalisation into the tumour cells. Subsequently, the release of DXd results in DNA damage and apoptotic cell death via topoisomerase I inhibition. |
| List of Excipients |
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L-histidine |
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.
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
EU/1/25/1915/001
| Drug | Countries | |
|---|---|---|
| DATROWAY | Austria, Estonia, Italy, Lithuania, United States |
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