{"entity":{"id":"mifamurtide","kind":"drug","name":"Mifamurtide","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Mifamurtide","links":[{"label":"EMA product information","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mepact"}],"tags":["gap-fill"],"related":[],"cancers":["osteosarcoma"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":[],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03643133","nct07787429","nct02441309"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"EU","year":2009,"indication":"High-grade resectable non-metastatic osteosarcoma after complete resection, with chemotherapy, ages 2-30"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mifamurtide/","neighbours":{"cancer":[{"id":"osteosarcoma","kind":"cancer","name":"Osteosarcoma","route":"/cancers/osteosarcoma/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"}],"company":[{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"trial":[{"id":"nct02441309","kind":"trial","name":"A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)","route":"/trials/nct02441309/"},{"id":"nct07787429","kind":"trial","name":"Evaluation of the Safety and Efficacy of Mifamurtide Versus Standard Treatment With Sorafenib in Patients With High-risk Osteosarcoma","route":"/trials/nct07787429/"},{"id":"nct03643133","kind":"trial","name":"Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients","route":"/trials/nct03643133/"}],"roadmap":[{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"}]}}