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.
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Synthetic NOD2 ligand delivered in liposomes to monocytes and macrophages, activating them to a tumoricidal state.
1.Mifamurtide slips into a pocket on its target.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request. Approved in the EU for osteosarcoma; the FDA declined approval in 2007.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE TA235 · SMC advice: mifamurtide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| EU | 2009 | High-grade resectable non-metastatic osteosarcoma after complete resection, with chemotherapy, ages 2-30 |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Mifamurtide" OR ABSTRACT:"Mifamurtide" OR TITLE:"Mepact" OR ABSTRACT:"Mepact") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Mifamurtide, not a curated reading list.
Shares Takeda, Cytokines & engineered cytokines.
Shares Takeda, Cytokines & engineered cytokines.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Osteosarcoma.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Osteosarcoma.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Osteosarcoma.
Shares Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first, Osteosarcoma.