daratumumab


( Last Updated : July 29, 2021)
Generic Name:
daratumumab
Project Status:
Active
Therapeutic Area:
Llight chain (AL) amyloidosis
Call for patient/clinician input open:
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0257-000
Call for patient/clinician input closed:
Tumour Type:
Other
NOC Status at Filing:
Post NOC

Details


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.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open June 16, 2021
Call for patient/clinician input closed August 09, 2021
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 15, 2021
Deadline for sponsors comments October 26, 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 13, 2021
To
December 15, 2021
Draft recommendation posted for stakeholder feedback  
End of feedback period