Last Updated : March 21, 2025
Details
FilesGeneric Name:
isatuximab
Project Status:
Active
Therapeutic Area:
multiple myeloma not eligible for ASCT
Manufacturer:
Sanofi-Aventis Canada Inc. (Sanofi)
Call for patient/clinician input open:
Brand Name:
Sarclisa
Project Line:
Reimbursement Review
Project Number:
PC0378-000
Call for patient/clinician input closed:
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Sarclisa (isatuximab for injection) is indicated in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT) or with no intent for ASCT as initial therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Sarclisa (isatuximab
for injection) is indicated in combination with bortezomib, lenalidomide and
dexamethasone, for the treatment of patients with newly diagnosed multiple
myeloma who are not eligible for autologous stem cell transplant (ASCT) or with
no intent for ASCT as initial therapy.
- 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 | September 17, 2024 |
|---|---|
| Call for patient/clinician input closed | November 12, 2024 |
| Submission received | October 30, 2024 |
| Submission accepted | November 14, 2024 |
| Review initiated | November 15, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | February 24, 2025 |
| Deadline for sponsors comments | March 05, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | March 28, 2025 |
| Expert committee meeting (initial) | April 09, 2025 |
| Draft recommendation issued to sponsor | April 23, 2025 To April 25, 2025 |
| Draft recommendation posted for stakeholder feedback | May 01, 2025 |
| End of feedback period | May 15, 2025 |
Files
Last Updated : March 21, 2025