TAFINLAR (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
TAFINLAR
Date registered
Evaluation commenced
Decision date
Approval time
197 (255 working days)
Active ingredients
dabrafenib mesilate
Registration type
EOI
Indication
Low-grade glioma
TAFINLAR in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 5.1 Clinical studies).
High-grade glioma
TAFINLAR in combination with trametinib is indicated for the treatment of paediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 5.1 Clinical studies).