Last Updated : November 22, 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 | March 21, 2024 |
|---|---|
| Call for patient/clinician input closed | May 13, 2024 |
| Submission received | May 01, 2024 |
| Submission accepted | May 15, 2024 |
| Review initiated | May 16, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | August 20, 2024 |
| Deadline for sponsors comments | August 29, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | September 26, 2024 |
| Expert committee meeting (initial) | October 09, 2024 |
| Draft recommendation issued to sponsor | October 22, 2024 |
| Draft recommendation posted for stakeholder feedback | October 31, 2024 |
| End of feedback period | November 15, 2024 |
| Clarification: - Reconsideration: major revisions requested by sponsor - Target pERC reconsideration meeting date to be determined | |
Files
Last Updated : November 22, 2024