Mirdametinib
Mirdametinib (Ezmekly, Merck Europe B.V. ) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Plexiform neurofibroma (NF1)1 | |||
None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1; aged 2 years and above |
Full text of section 4.1 (therapeutic indications)
Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.
Label history
5 changes to the Ezmekly label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes