Spexotras is a cancer medicine used to treat children aged 1 year and older with glioma (a type of brain tumour). It is used together with another cancer medicine, dabrafenib. Spexotras is only used in patients whose glioma cancer cells have a specific mutation (change) in the BRAF gene called BRAF V600E. Spexotras can be used in children with: - low-grade glioma who require systemic therapy (a treatment that affects the whole body); - high-grade glioma when the patient has previously received at least one treatment with radiation or chemotherapy. Spexotras contains the active substance trametinib.
Therapeutic Indication
### Therapeutic indication Low-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
Therapeutic Area (MeSH)
N/AATC Code
L01EE01
ATC Item
trametinib
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/AEMA Name
Spexotras
Medicine Name
Spexotras
Aliases
N/ANo risk management plan link.