Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

quizartinib

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Generic Name:
quizartinib
Project Status:
Active
Therapeutic Area:
acute myeloid leukemia (AML)
Manufacturer:
Daiichi Sankyo Pharma Canada
Call for patient/clinician input open:
Brand Name:
Vanflyta
Project Line:
Reimbursement Review
Project Number:
PC0359-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Vanflyta (quizartinib) is indicated in combination with standard cytarabineand anthracycline induction and standard cytarabine consolidationchemotherapy, and as continuation maintenance monotherapy followingconsolidation, for the treatment of adult patients with newly diagnosed acutemyeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandemduplication (FLT3-ITD) positive.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​Vanflyta (quizartinib) is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation maintenance monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive. 
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open30-Oct-24
Call for patient/clinician input closed20-Dec-24
Submission received11-Dec-24
Submission accepted02-Jan-25
Review initiated03-Jan-25
Draft CADTH review report(s) provided to sponsor for comment21-Mar-25
Deadline for sponsors comments01-Apr-25
CADTH review report(s) and responses to comments provided to sponsor02-May-25
Expert committee meeting (initial)14-May-25
Draft recommendation issued to sponsorMay 27, 2025
To
May 29, 2025
Draft recommendation posted for stakeholder feedback05-Jun-25
End of feedback period19-Jun-25

Files

Patient and Clinician Group Input View PDF
Last Updated : January 3, 2025