MEKINIST (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
MEKINIST
Date registered
Evaluation commenced
Decision date
Approval time
205 (255 working days)
Active ingredients
trametinib dimethyl sulfoxide
Registration type
EOI
Indication
Low-grade glioma
Mekinist in combination with dabrafenib 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
Mekinist in combination with dabrafenib 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).