Last Updated : November 18, 2024
Details
FilesGeneric Name:
talquetamab
Project Status:
Active
Therapeutic Area:
Relapsed or refractory multiple myeloma
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Talvey
Project Line:
Reimbursement Review
Project Number:
PC0363-000
Call for patient/clinician input closed:
Tumour Type:
Myeloma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on or after the last therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on or after the last therapy.
- 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 | 21-Mar-24 |
---|---|
Call for patient/clinician input closed | 13-May-24 |
Submission received | 01-May-24 |
Submission accepted | 15-May-24 |
Review initiated | 16-May-24 |
Draft CADTH review report(s) provided to sponsor for comment | 20-Aug-24 |
Deadline for sponsors comments | 29-Aug-24 |
CADTH review report(s) and responses to comments provided to sponsor | 26-Sep-24 |
Expert committee meeting (initial) | 09-Oct-24 |
Draft recommendation issued to sponsor | 22-Oct-24 |
Draft recommendation posted for stakeholder feedback | 31-Oct-24 |
End of feedback period | 15-Nov-24 |
Clarification: - Reconsideration: major revisions requested by sponsor |
Files
Last Updated : November 18, 2024