Last Updated : December 3, 2024
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Unresectable or metastatic MSI-H or dMMR solid tumors
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0377-000
Call for patient/clinician input closed:
Tumour Type:
Other
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab as
monotherapy for the treatment of adult and pediatric patients with unresectable
or metastatic microsatellite instability-high (MSI-H) or mismatch repair
deficient (dMMR) solid tumors, as determined by a validated test, that have
progressed following prior treatment and who have no
satisfactory alternative treatment options.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Indications:
Pembrolizumab as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
- 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 | 05-Jun-24 |
---|---|
Call for patient/clinician input closed | 26-Jul-24 |
Submission received | 16-Jul-24 |
Submission accepted | - |
Review initiated | 31-Jul-24 |
Draft CADTH review report(s) provided to sponsor for comment | 17-Oct-24 |
Deadline for sponsors comments | 28-Oct-24 |
CADTH review report(s) and responses to comments provided to sponsor | 22-Nov-24 |
Expert committee meeting (initial) | 04-Dec-24 |
Draft recommendation issued to sponsor | December 16, 2024 To December 18, 2024 |
Draft recommendation posted for stakeholder feedback | 02-Jan-25 |
End of feedback period | 16-Jan-25 |
Files
Last Updated : December 3, 2024