Brentuximab Vedotin

Therapeutic Brentuximab Vedotin antibody from the original Adcetris® commercial drug

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Product
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Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
CD30
Antibody-drug conjugate (ADC)
Adcetris®
5 mg/mL
2 mg
2-8°C / -80°C
01/2024
888,00 
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Adcetris® / Brentuximab Vedotin Reference Product

Drug nameAdcetris®
INNBrentuximab Vedotin
API typeBrentuximab Vedotin is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE)
Pharmacotherapeutic group
Antineoplastic agents
ATC code
L01XC12
Target of antibody
CD-30
General functionThe monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells. The cytotoxic molecule then enters the cancer cells and stops them from dividing, and the cancer cells eventually die.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Brentuximab vedotin is an ADC that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)The primary objective was to evaluate the effect of brentuximab vedotin on cardiac ventricular re-polarization and the predefined primary analysis was the change in QTc from baseline to multiple time points in Cycle 1.
The upper 90% confidence interval (CI) around the mean effect on QTc was < 10 msec at each of the Cycle 1 and Cycle 3 post-baseline time points. These data indicate the absence of clinically relevant QT prolongation due to brentuximab vedotin administered at a dose of 1.8 mg/kg every 3 weeks in patients with CD30-expressing malignancies.
Original license holder
Takeda Pharma A/S
Marketing authorisation numbers
EU/1/03/256/022
Marketing authorisation holder
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
Name of the manufacturer of the biological active substance
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
Name and address of the manufacturer(s) responsible for batch releaseTakeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
Max shelf life
48 months
Storage conditions
2°C – 8°C
List of excipients
Citric acid monohydrate
Sodium citrate dihydrate
α,α-Trehalose dihydrate
Polysorbate 80
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