Difference between revisions of "Quizartinib (Vanflyta)"
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==Mechanism of action== | ==Mechanism of action== | ||
FLT3 inhibitor | FLT3 inhibitor | ||
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| + | ==Toxicity management== | ||
| + | *[https://vanflytarems.com/ Link to REMS program] | ||
==Diseases for which it is established== | ==Diseases for which it is established== | ||
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*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 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)'' | *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 EMA indication== | ||
| + | *2023-09-14: CHMP recommended marketing authorization at Vanflyta. Vanflyta would be indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive. | ||
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==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]]. | ||
| + | *2023-05-25: New indication and a new dosage for the treatment of newly diagnosed FLT3-ITD mutation-positive [[acute myeloid leukemia]]. | ||
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==Also known as== | ==Also known as== | ||
*'''Code names:''' AC-220, ASP-2689 | *'''Code names:''' AC-220, ASP-2689 | ||
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[[Category:PMDA approved in 2019]] | [[Category:PMDA approved in 2019]] | ||
[[Category:FDA approved in 2023]] | [[Category:FDA approved in 2023]] | ||
| + | [[Category:REMS program]] | ||
Latest revision as of 03:41, 1 June 2024
Mechanism of action
FLT3 inhibitor
Toxicity management
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 EMA indication
- 2023-09-14: CHMP recommended marketing authorization at Vanflyta. Vanflyta would be indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
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.
- 2023-05-25: New indication and a new dosage for the treatment of newly diagnosed FLT3-ITD mutation-positive acute myeloid leukemia.
Also known as
- Code names: AC-220, ASP-2689
- Brand name: Vanflyta