Gemtuzumab Ozogamicin Drug Aliquot | Anti-CD33 | Therapeutic ADC

Aliquoted from the original reference drug | Now available for research use

Aliquots of the reference drug Gemtuzumab Ozogamicin (Mylotarg®) are now available as research consumables.

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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Mylotarg® / Gemtuzumab Ozogamicin Reference Product

Drug nameMylotarg®
INNGemtuzumab Ozogamicin
API typeGemtuzumab 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 functionThe 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 releasePfizer 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

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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.

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