Last Updated : March 21, 2025
Details
FilesGeneric 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.
- 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.
| Call for patient/clinician input open | October 30, 2024 |
|---|---|
| Call for patient/clinician input closed | December 20, 2024 |
| Submission received | December 11, 2024 |
| Submission accepted | January 02, 2025 |
| Review initiated | January 03, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | March 21, 2025 |
| Deadline for sponsors comments | April 01, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | May 02, 2025 |
| Expert committee meeting (initial) | May 14, 2025 |
| Draft recommendation issued to sponsor | May 27, 2025 To May 29, 2025 |
| Draft recommendation posted for stakeholder feedback | June 05, 2025 |
| End of feedback period | June 19, 2025 |
Files
Last Updated : March 21, 2025