Metastatic Merkel cell carcinoma (MCC)

Active Ingredient: Avelumab

Indication for Avelumab

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

Avelumab is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

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

10 mg/kg once every 2 weeks

Route of admnistration

Intravenous

Defined daily dose

10 - 10 mg per kg of body weight

Dosage regimen

From 10 To 10 mg per kg of body weight once every 14 day(s)

Detailed description

The recommended dose of avelumab is 10 mg/kg body weight administered intravenously over 60 minutes every 2 weeks.

Administration of avelumab should continue according to the recommended schedule until disease progression or unacceptable toxicity. Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than two weeks, and no need for salvage therapy, could continue treatment.

Premedication

Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of avelumab. If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.

Dosage considerations

Intravenously over 60 minutes.

Active ingredient

Avelumab

Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1). Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors. This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.

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