Plexiform neurofibroma (NF1)

The EU has approved 3 indications of 2 drugs in plexiform neurofibroma (NF1). None of them needs a biomarker result.

Line of therapy

Approved indications, Plexiform neurofibroma (NF1)
DrugBiomarker requirementRegimenSettingConditions
No biomarker required3
Mirdametinib
Ezmeklyconditional
None
Monotherapy
Any line
Symptomatic; inoperable; neurofibromatosis type 1; aged 2 years and above
Selumetinib
Koselugoconditional
None
Monotherapy
Any line
Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 3 years and older
Selumetinib
Koselugoconditional
None
Monotherapy
Any line
Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 1 year to less than 7 years, or older patients with swallowing difficulties
Label wording3

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Selumetinib (Koselugo)
    Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older.
  2. Selumetinib (Koselugo)
    Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.
  3. Mirdametinib (Ezmekly)
    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.