# Mifamurtide

Source: https://onco.cc/drugs/mifamurtide/  
OnCo record `mifamurtide` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An immune-activating drug approved in Europe for osteosarcoma after a trial suggested it improved survival; the FDA never approved it, and it remains one of oncology's transatlantic disagreements.

## Summary

Mifamurtide is a synthetic muramyl tripeptide, a NOD2 ligand, packaged in liposomes so it is taken up by monocytes and macrophages and switches them to a tumour-killing state. It is given with chemotherapy after complete resection of high-grade non-metastatic osteosarcoma in patients aged 2 to 30. In the INT-0133 trial (Meyers, JCO 2008) six-year overall survival was 78% versus 70% when mifamurtide was added to MAP chemotherapy, but the factorial design, confounded by a parallel ifosfamide question, made interpretation contentious. The EMA approved it in 2009 while the FDA issued a not-approvable letter in 2007, and the transatlantic disagreement persists. Chills, fever and fatigue are the typical infusion effects. Mifamurtide is an immune-activating drug whose benefit in bone cancer is accepted in Europe and doubted in the US on the same data.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Mepact
- Modality: Liposomal muramyl tripeptide (macrophage activator)
- Mechanism: Synthetic NOD2 ligand delivered in liposomes to monocytes and macrophages, activating them to a tumoricidal state.
- Approvals: EU 2009: High-grade resectable non-metastatic osteosarcoma after complete resection, with chemotherapy, ages 2-30

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Mifamurtide
- EMA product information: https://www.ema.europa.eu/en/medicines/human/EPAR/mepact

## Connected records

- cancers: [Osteosarcoma](https://onco.cc/cancers/osteosarcoma/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/)
- companies: [Takeda](https://onco.cc/companies/takeda/)
- trials: [A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)](https://onco.cc/trials/nct02441309/), [Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma](https://onco.cc/trials/nct07787429/), [Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients](https://onco.cc/trials/nct03643133/)
- roadmaps: [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/)

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