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Koselugo
Published
Product name
Koselugo
Active ingredient
Selumetinib sulfate
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Koselugo was approved for the following therapeutic use:
Koselugo is indicated for the treatment of paediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
How this medicine works
Selumetinib is an orally available, inhibitor of mitogen activated protein kinase kinases 1 and 2 (MEK1/2) that is not competitive with respect to adenosine triphosphate (ATP). MEK1/2 proteins are critical components of the reticular activating system (RAS)-regulated rapidly accelerated fibrosarcoma (RAF)-mitogen activated protein kinase (MEK)-extracellular signal regulated kinases (ERK) pathway, which is often activated in different types of cancers. Selumetinib blocks MEK activity and inhibits growth of RAF-MEK-ERK pathway activated cell lines. Therefore, MEK inhibition can block the proliferation and survival of tumour cells in which the RAF-MEK-ERK pathway is activated.
Why the TGA approved or did not approve this medicine
The decision was based on nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Koselugo was considered favourable for the therapeutic use approved.
Sponsor