Systemic anaplastic large cell lymphoma (sALCL)

Active Ingredient: Brentuximab vedotin

Indication for Brentuximab vedotin

Population group: only adults (18 years old or older)

Brentuximab vedotin is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

For this indication, competent medicine agencies globally authorize below treatments:

1.8 mg/kg once every 3 weeks

Route of admnistration

Intravenous

Defined daily dose

1.8 - 1.8 mg per kg of body weight

Dosage regimen

From 1.8 To 1.8 mg per kg of body weight once every 21 day(s)

Detailed description

The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.

The recommended starting dose for the retreatment of patients who have previously responded to treatment with brentuximab vedotin is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Alternatively, treatment may be started at the last tolerated dose.

Treatment should be continued until disease progression or unacceptable toxicity.

Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year).

Dosage considerations

The recommended dose of brentuximab vedotin is infused over 30 minutes.

Active ingredient

Brentuximab vedotin

Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells. Nonclinical data suggest that the biological activity of brentuximab vedotin results from a multi-step process. Binding of the ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment. Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.

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