Difference between revisions of "Selumetinib (Koselugo)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
 
''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.''
*4/10/2020: Approved for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable [[Plexiform neurofibroma|plexiform neurofibromas (PN)]].
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*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==
 +
*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==
 
==Also known as==
*'''Code name:''' AZD6244
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*'''Code name:''' AZD-6244
 
*'''Brand name:''' Koselugo
 
*'''Brand name:''' Koselugo
  
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[[Category:Low-grade serous ovarian cancer medications]]
 
[[Category:Low-grade serous ovarian cancer medications]]
[[Category:Differentiated thyroid cancer medications]]
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[[Category:Thyroid cancer, differentiated medications]]
 
[[Category:Uveal melanoma medications]]
 
[[Category:Uveal melanoma medications]]
  
 
[[Category:FDA approved in 2020]]
 
[[Category:FDA approved in 2020]]
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[[Category:EMA approved in 2020]]
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[[Category:PMDA approved in 2022]]

Latest revision as of 23:29, 17 August 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: AZD-6244
  • Brand name: Koselugo