Last Updated : January 29, 2025
Details
FilesGeneric Name:
daratumumab
Project Status:
Complete
Therapeutic Area:
Light chain (AL) amyloidosis
Manufacturer:
Janssen Inc.
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0257-000
Tumour Type:
Other
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Darzalex SC in combination with bortezomib, cyclophosphamide, and dexamethasone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Darzalex SC in combination with bortezomib, cyclophosphamide, and dexamethasone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | June 16, 2021 |
|---|---|
| Call for patient/clinician input closed | August 09, 2021 |
| Clarification: - Patient input submission received from Myeloma Canada | |
| Submission received | July 15, 2021 |
| Submission accepted | July 29, 2021 |
| Review initiated | July 30, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | October 20, 2021 |
| Deadline for sponsors comments | October 29, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | November 19, 2021 |
| Expert committee meeting (initial) | December 01, 2021 |
| Draft recommendation issued to sponsor | December 15, 2021 |
| Draft recommendation posted for stakeholder feedback | December 23, 2021 |
| End of feedback period | January 14, 2022 |
| Final recommendation posted | February 15, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 11, 2022 |
| CADTH review report(s) posted | May 16, 2022 |
Files
Last Updated : January 29, 2025