Last Updated : September 5, 2024
Details
FilesGeneric Name:
ivosidenib
Project Status:
Active
Therapeutic Area:
Acute myeloid leukemia (AML)
Manufacturer:
Servier Canada Inc
Call for patient/clinician input open:
Brand Name:
Tibsovo
Project Line:
Reimbursement Review
Project Number:
PC0349-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ivosidenib in combination
with azacitidine is indicated for the treatment of adult patients with newly
diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1
(IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
TIBSOVO (ivosidenib) in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy.
- 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 | 05-Feb-24 |
|---|---|
| Call for patient/clinician input closed | 02-Apr-24 |
| Clarification: - Patient input submission received from The Leukemia and Lymphoma Society of Canada (LLSC) and Heal Canada | |
| Submission received | 19-Mar-24 |
| Submission accepted | 03-Apr-24 |
| Review initiated | 04-Apr-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 21-Jun-24 |
| Deadline for sponsors comments | 03-Jul-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 01-Aug-24 |
| Expert committee meeting (initial) | 14-Aug-24 |
| Draft recommendation issued to sponsor | 28-Aug-24 |
| Draft recommendation posted for stakeholder feedback | 05-Sep-24 |
| End of feedback period | 19-Sep-24 |
Files
Last Updated : September 5, 2024