Difference between revisions of "Quizartinib (Vanflyta)"

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'''Note: this drug is only approved in Japan, at this time.'''
 
 
==Mechanism of action==
 
==Mechanism of action==
 
FLT3 inhibitor
 
FLT3 inhibitor
  
==Diseases for which it is used==
+
==Diseases for which it is established==
===[[Acute_myeloid_leukemia,_FLT3-positive|FLT3+ AML]]===
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*[[Acute_myeloid_leukemia,_FLT3-positive|FLT3+ AML]]
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==History of changes in FDA indication==
 +
*2023-07-20: Approved with standard cytarabine and anthracycline induction for the treatment of adult patients with newly diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. ''(Based on QuANTUM-First)''
 +
*2023-07-20: Approved with cytarabine consolidation for the treatment of adult patients with newly diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. ''(Based on QuANTUM-First)''
 +
*2023-07-20: Approved as maintenance monotherapy following consolidation chemotherapy for the treatment of adult patients with newly diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. ''(Based on QuANTUM-First)''
 
==History of changes in PMDA indication==
 
==History of changes in PMDA indication==
 
*2019-06-18: Newly indicated for the treatment of relapsed or refractory FLT3-ITD mutation-positive [[acute myeloid leukemia]].
 
*2019-06-18: Newly indicated for the treatment of relapsed or refractory FLT3-ITD mutation-positive [[acute myeloid leukemia]].
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[[Category:PMDA approved in 2019]]
 
[[Category:PMDA approved in 2019]]
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[[Category:FDA approved in 2023]]

Revision as of 01:35, 21 July 2023

Mechanism of action

FLT3 inhibitor

Diseases for which it is established

History of changes in FDA indication

  • 2023-07-20: Approved with standard cytarabine and anthracycline induction for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. (Based on QuANTUM-First)
  • 2023-07-20: Approved with cytarabine consolidation for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. (Based on QuANTUM-First)
  • 2023-07-20: Approved as maintenance monotherapy following consolidation chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. (Based on QuANTUM-First)

History of changes in PMDA indication

  • 2019-06-18: Newly indicated for the treatment of relapsed or refractory FLT3-ITD mutation-positive acute myeloid leukemia.

Also known as

  • Code names: AC220, ASP2689
  • Brand name: Vanflyta