Canada’s Drug Agency | Drugs, Health Technologies and Systems.

daratumumab

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Generic 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.
  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 open19-Aug-24
Call for patient/clinician input closed15-Oct-24
Submission received01-Oct-24
Submission accepted16-Oct-24
Draft CADTH review report(s) provided to sponsor for comment17-Jan-25
Deadline for sponsors comments29-Jan-25
CDA-AMC review report(s) and responses to comments provided to sponsor28-Feb-25
Expert committee meeting (initial)12-Mar-25
Draft recommendation issued to sponsor25-Mar-25
Draft recommendation posted for stakeholder feedback03-Apr-25
End of feedback period17-Apr-25
Final recommendation issued to sponsor and drug plans02-May-25
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)16-May-25
CDA-AMC review report(s) posted-

Files

Draft Recommendations & Reasons View PDF
Patient and Clinician Group input View PDF
Last Updated : April 23, 2025