Last Updated : April 24, 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).
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).
- 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 | 17-Sep-24 |
|---|---|
| Call for patient/clinician input closed | 12-Nov-24 |
| Submission received | 30-Oct-24 |
| Submission accepted | 14-Nov-24 |
| Review initiated | 15-Nov-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 24-Feb-25 |
| Deadline for sponsors comments | 05-Mar-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 28-Mar-25 |
| Expert committee meeting (initial) | 09-Apr-25 |
| Draft recommendation issued to sponsor | 24-Apr-25 |
| Draft recommendation posted for stakeholder feedback | 01-May-25 |
| End of feedback period | 15-May-25 |
Files
Last Updated : April 24, 2025