Mifamurtide
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.
INT-0133 (Meyers, JCO 2008): 6-year OS 78% vs 70% when added to MAP chemotherapy, but a factorial design confounded by ifosfamide made interpretation contentious. EMA approved 2009; FDA issued a not-approvable letter (2007). Chills, fever, fatigue.
- Medicare
- Not covered (not FDA-approved)
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.
- Commercial insurance
- unknown
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.
- Appraised for
- High-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection (age 2-30)
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA235 · SMC advice: mifamurtide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| EU | 2009 | High-grade resectable non-metastatic osteosarcoma after complete resection, with chemotherapy, ages 2-30 |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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