Difference between revisions of "Quizartinib (Vanflyta)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
 
(15 intermediate revisions by 2 users not shown)
Line 2: Line 2:
 
FLT3 inhibitor
 
FLT3 inhibitor
  
−
==Preliminary data==
+
==Toxicity management==
−
===[[Acute_myeloid_leukemia,_FLT3-positive|FLT3+ AML]]===
+
*[https://vanflytarems.com/ Link to REMS program]
−
# '''Phase 1:''' Cortes JE, Kantarjian H, Foran JM, Ghirdaladze D, Zodelava M, Borthakur G, Gammon G, Trone D, Armstrong RC, James J, Levis M. Phase I study of quizartinib administered daily to patients with relapsed or refractory acute myeloid leukemia irrespective of FMS-like tyrosine kinase 3-internal tandem duplication status. J Clin Oncol. 2013 Oct 10;31(29):3681-7. Epub 2013 Sep 3. [http://jco.ascopubs.org/content/31/29/3681.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24002496 PubMed]
+
 
−
<!--
+
==Diseases for which it is established==
−
# '''Abstract:''' Jorge E. Cortes, Alexander E Perl, Hervé Dombret, Sabine Kayser, Björn Steffen, Philippe Rousselot, Giovanni Martinelli, Elihu H. Estey, Alan K Burnett, Guy Gammon, Denise Trone, Eugen Leo, and Mark J. Levis Final Results of a Phase 2 Open-Label, Monotherapy Efficacy and Safety Study of Quizartinib (AC220) in Patients ≥ 60 Years of Age with FLT3 ITD Positive or Negative Relapsed/Refractory Acute Myeloid Leukemia Blood (ASH Annual Meeting Abstracts), Nov 2012; 120: 48. [http://abstracts.hematologylibrary.org/cgi/content/abstract/120/21/48 link to abstract] -->
+
*[[Acute_myeloid_leukemia,_FLT3-positive|FLT3+ AML]]
−
# '''ACE:''' Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. Epub 2018 May 31. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30240-7/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29859851 PubMed]
+
==History of changes in FDA indication==
−
# '''2689-CL-2004:''' Cortes JE, Tallman MS, Schiller GJ, Trone D, Gammon G, Goldberg SL, Perl AE, Marie JP, Martinelli G, Kantarjian HM, Levis MJ. Phase 2b study of 2 dosing regimens of quizartinib monotherapy in FLT3-ITD-mutated, relapsed or refractory AML. Blood. 2018 Aug 9;132(6):598-607. Epub 2018 Jun 6. [http://www.bloodjournal.org/content/132/6/598.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29875101 PubMed]
+
*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 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==
 
==Also known as==
−
*'''Code names:''' AC220, ASP2689
+
*'''Code names:''' AC-220, ASP-2689
 +
*'''Brand name:''' Vanflyta
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
  
−
[[Category:Kinase inhibitors]]
 
 
[[Category:FLT3 inhibitors]]
 
[[Category:FLT3 inhibitors]]
  
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
  
−
[[Category:Investigational]]
+
[[Category:PMDA approved in 2019]]
 +
[[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
Retrieved from "https://hemonc.org/w/index.php?title=Quizartinib_(Vanflyta)&oldid=86122"