GOMEKLI Merck Healthcare Pty Ltd
Product name
GOMEKLI
Sponsor
Accepted date
Jun-2026
Active ingredients
mirdametinib
Summary of proposed indication
GOMEKLI (mirdametinib) is proposed to treat plexiform neurofibromas, tumours that grow along nerves that can cause pain and functional impairments. GOMEKLI is proposed for use where the tumours cannot be fully removed completely with surgery. It is intended for use in adults and children aged 2 years and older who have neurofibromatosis type 1, a genetic condition that increases the risk of developing these tumours.
Application type
A (new medicine)
Publication date
Jun-2026
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.