Difference between revisions of "Selumetinib (Koselugo)"
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''Note: this is not an antineoplastic indication. This drug does have some preliminary data in cancer settings.'' | ''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 neurofibroma|plexiform neurofibromas (PN)]]. | *2020-04-10: Approved for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable [[Plexiform neurofibroma|plexiform neurofibromas (PN)]]. | ||
| + | ==History of changes in EMA indication== | ||
| + | *2020-04-10: Initial marketing authorisation. | ||
==History of changes in PMDA indication== | ==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. | *2022-09-26: Drugs with a new active ingredient indicated for the treatment of [[plexiform neurofibroma]] in patients with neurofibromatosis type 1. | ||
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[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:EMA approved in 2020]] | ||
[[Category:PMDA approved in 2022]] | [[Category:PMDA approved in 2022]] | ||
Revision as of 20:32, 15 June 2023
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: AZD6244
- Brand name: Koselugo