Selumetinib
Selumetinib (Koselugo, AstraZeneca AB) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Plexiform neurofibroma (NF1)2 | |||
None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 3 years and older |
None | Monotherapy | Any line | Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 1 year to less than 7 years, or older patients with swallowing difficulties |
Full text of section 4.1 (therapeutic indications)
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. 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.
Label history
10 changes to the Koselugo label since 2022, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes