Basic Information
Finlee
Regulatory Information
EMEA/H/C/005885
November 15, 2023
September 14, 2023
6
August 20, 2024
Company Information
Ireland
Vista Building Elm Park, Merrion Road Dublin 4
NOVARTIS EUROPHARM LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Low-grade glioma** Finlee in combination with trametinib 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** Finlee in combination with trametinib 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.
Overview Summary
Finlee 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, trametinib. Finlee is only used in patients whose glioma cancer cells have a specific mutation (change) in the BRAF gene called ‘BRAF V600E’. Finlee can be used in children with: - low-grade glioma who require systemic therapy; - high-grade glioma when the patient has received at least one prior radiation or chemotherapy treatment. Glioma is rare, and Finlee was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2020. Finlee contains the active substance dabrafenib.