Last Updated : November 25, 2024
Details
FilesGeneric Name:
ciltacabtagene autoleucel
Project Status:
Active
Therapeutic Area:
Relapsed or refractory multiple myeloma
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Carvykti
Project Line:
Reimbursement Review
Project Number:
PG0361-000
Call for patient/clinician input closed:
Tumour Type:
Myeloma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with multiple myeloma who have received 1 to 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
• For the treatment of adult patients with multiple myeloma, who have received 1 to 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.• For the treatment of adult patients with multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and who are refractory to their last treatment.
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 | 06-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 30-Apr-24 |
| Clarification: - Patient input submission received from Myeloma Canada | |
| Submission received | 18-Apr-24 |
| Submission accepted | 03-May-24 |
| Review initiated | 06-May-24 |
| Draft Canada's Drug Agency review report(s) provided to sponsor for comment | 24-Jul-24 |
| Deadline for sponsors comments | 02-Aug-24 |
| Canada's Drug Agency review report(s) and responses to comments provided to sponsor | 29-Aug-24 |
| Expert committee meeting (initial) | 11-Sep-24 |
| Draft recommendation issued to sponsor | 24-Sep-24 |
| Draft recommendation posted for stakeholder feedback | 03-Oct-24 |
| End of feedback period | 18-Oct-24 |
| Final recommendation issued to sponsor and drug plans | 01-Nov-24 |
| Final recommendation posted | 20-Nov-24 |
| Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s) | 18-Nov-24 |
| Canada's Drug Agency review report(s) posted | - |
Files
Last Updated : November 25, 2024