Selumetinib (Koselugo)

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Mechanism of action

Inhibits the enzyme MAPK kinase (MEK), specifically the MEK1 and MEK2 subtypes of the enzyme.

Diseases for which it is used

History of changes in FDA indication

Note: this is not an antineoplastic indication. This drug does have some preliminary data in cancer settings.

  • 2020-04-10: Approved for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

History of changes in EMA indication

  • 2020-04-10: Initial marketing authorisation.

History of changes in PMDA indication

  • 2022-09-26: Drugs with a new active ingredient indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1.

Also known as

  • Code name: AZD-6244
  • Brand name: Koselugo