FINLEE / SPEXOTRAS (dabrafenib / trametinib)

The Committee deems that the clinical benefit of FINLEE (dabrafenib) 10 mg dispersible tablet and SPEXOTRAS (trametinib) 0.05 mg/mL powder for oral solution is substantial in the MA indications.

The combination of FINLEE (dabrafenib) 10 mg dispersible tablet and SPEXOTRAS (trametinib) 0.05 mg/mL powder for oral solution provides a minor clinical added value (CAV IV) compared to carboplatin plus vincristine chemotherapy in the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

The combination of FINLEE (dabrafenib) 10 mg dispersible tablet and SPEXOTRAS (trametinib) 0.05 mg/mL powder for oral solution provides a minor clinical added value (CAV IV) in the care pathway for 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.