VORANIGO (Servier Laboratories (Aust) Pty Ltd)
Product name
VORANIGO
Date registered
Evaluation commenced
Decision date
Approval time
133 (255 working days)
Active ingredients
vorasidenib
Registration type
NCE/ NBE
Indication
VORANIGO is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and paediatric patients 12 years and older, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.