Non-metastatic osteosarcoma

Active Ingredient: Mifamurtide

Indication for Mifamurtide

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)

Mifamurtide is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.

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

2 mg/m² twice weekly

Route of admnistration


Defined daily dose

2 - 2 mg per m² of body surface area (BSA)

Dosage regimen

From 2 To 2 mg per m² of body surface area (BSA) once every 3 day(s)

Detailed description

The recommended dose of mifamurtide for all patients is 2 mg/m² body surface area. It should be administered as adjuvant therapy following resection: twice weekly at least 3 days apart for 12 weeks, followed by once-weekly treatments for an additional 24 weeks for a total of 48 infusions in 36 weeks.

Dosage considerations

It is administered by intravenous infusion over a period of 1 hour.

Active ingredient


Mifamurtide (MTP-PE) is a fully synthetic derivative of muramyl dipeptide (MDP). MTP-PE is a potent activator of monocytes and macrophages. The exact mechanism by which mifamurtide activation of monocytes and macrophages leads to anti-tumour activity in animals and humans is not yet known.

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