Gemtuzumab ozogamicin drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Gemtuzumab ozogamicin drug can be ordered at the same time. Several other reference drugs are also available.
The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.
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Up to 10 batches of original drugs for examining batch-to-batch variations
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| Drug name | Mylotarg® |
| INN | Gemtuzumab Ozogamicin |
| API type | Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. |
| Pharmacotherapeutic group | Antineoplastic agents |
| ATC code | L01XC05 |
| Target of antibody | CD-33 |
| General function | The monoclonal antibody part (gemtuzumab) has been designed to attach to CD33. When the antibody attaches to CD33 on leukaemia cells, the cells absorb the antibody, as well as the cytotoxic substance that it is attached to. Inside the cells, the cytotoxic substance, which is called calicheamicin, is released. The calicheamicin then breaks up the cells’ DNA, eventually killing the cells. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Gemtuzumab ozogamicin is a CD33-directed ADC. Gemtuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody which specifically recognises human CD33. The antibody portion binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of myeloid leukaemic blasts and immature normal cells of myelomonocytic lineage, but not on normal haematopoietic stem cells. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product. N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy)butanoic acid) linker. Non-clinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing cancer cells, followed by internalisation of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | The efficacy and safety of MYLOTARG were evaluated in a multicentre, randomised, open-label Phase 3 study comparing the addition of MYLOTARG to a standard chemotherapy induction regimen of daunorubicin and cytarabine (DA) versus DA alone. Eligible patients were between 50 and 70 years of age with previously untreated de novo AML (Study ALFA-0701). The primary endpoint was event-free survival (EFS). The secondary endpoints included CR and CRp rates, relapse-free survival (RFS), overall survival (OS), and safety of the combination DA with or without MYLOTARG. The trial met its primary objective of demonstrating that MYLOTARG added in fractionated doses (3 mg/m2 × 3) to standard induction chemotherapy for patients with previously untreated de novo AML resulted in a statistically significant and clinically meaningful improvement in EFS. Median EFS was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/18/1277/001 |
| Marketing authorisation holder | Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium |
| Name of the manufacturer of the biological active substance | Wyeth Pharmaceutical Division of Wyeth Holdings LLC, 401 North Middletown Road, Pearl River, New York 10965 United States |
| Name and address of the manufacturer(s) responsible for batch release | Pfizer Service Company BV Hoge Wei 10 1930, Zaventem Belgium |
| Max shelf life | 60 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Dextran 40 Sucrose Sodium chloride Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous |
Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.
Evidentic GmbH
Am Mühlenberg 10
14476 Potsdam | Germany
