isatuximab

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Generic 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.
  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 openSeptember 17, 2024
Call for patient/clinician input closedNovember 12, 2024
Submission receivedOctober 30, 2024
Submission acceptedNovember 14, 2024
Review initiatedNovember 15, 2024
Draft CADTH review report(s) provided to sponsor for commentFebruary 24, 2025
Deadline for sponsors commentsMarch 05, 2025
CADTH review report(s) and responses to comments provided to sponsorMarch 28, 2025
Expert committee meeting (initial)April 09, 2025
Draft recommendation issued to sponsorApril 23, 2025
To
April 25, 2025
Draft recommendation posted for stakeholder feedbackMay 01, 2025
End of feedback periodMay 15, 2025