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Therapeutic Brentuximab Vedotin antibody from the original Adcetris® commercial drug.
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| Drug name | Adcetris® |
| INN | Brentuximab Vedotin |
| API type | Brentuximab 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 function | The 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 release | Takeda 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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