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 openAugust 19, 2024
Call for patient/clinician input closedOctober 15, 2024
Submission receivedOctober 01, 2024
Submission acceptedOctober 16, 2024
Draft CADTH review report(s) provided to sponsor for commentJanuary 17, 2025
Deadline for sponsors commentsJanuary 29, 2025
CADTH review report(s) and responses to comments provided to sponsorFebruary 28, 2025
Expert committee meeting (initial)March 12, 2025
Draft recommendation issued to sponsorMarch 25, 2025
Draft recommendation posted for stakeholder feedbackApril 03, 2025
End of feedback periodApril 17, 2025