Last Updated : March 25, 2025
Details
FilesGeneric Name:
daratumumab
Project Status:
Active
Therapeutic Area:
Multiple myeloma, eligible for autologous stem cell transplant
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Darzalex SC
Project Line:
Reimbursement Review
Project Number:
PC0388-000
Call for patient/clinician input closed:
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Darzalex SC (daratumumab injection) is indicated in combination with bortezomib, lenalidomide, and dexamethasone, followed by maintenance treatment in combination with lenalidomide, for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Darzalex SC (daratumumab injection) is indicated in combination with bortezomib, lenalidomide, and dexamethasone, followed by maintenance treatment in combination with lenalidomide, for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
- 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 | August 19, 2024 |
|---|---|
| Call for patient/clinician input closed | October 15, 2024 |
| Submission received | October 01, 2024 |
| Submission accepted | October 16, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | January 17, 2025 |
| Deadline for sponsors comments | January 29, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | February 28, 2025 |
| Expert committee meeting (initial) | March 12, 2025 |
| Draft recommendation issued to sponsor | March 25, 2025 |
| Draft recommendation posted for stakeholder feedback | April 03, 2025 |
| End of feedback period | April 17, 2025 |
Files
Last Updated : March 25, 2025