Last Updated : January 6, 2025
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Non-Small Cell Lung Cancer, neoadjuvant
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0385-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda (pembrolizumab)
is indicated for the treatment of adult patients with resectable stage II,
IIIA, or IIIB (T3-4N2) NSCLC in combination with platinum containing
chemotherapy as neoadjuvant treatment, and then continued as monotherapy as
adjuvant treatment.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Keytruda (pembrolizumab) is indicated for the treatment of adult patients with resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC in combination with platinum containing chemotherapy as neoadjuvant treatment, and the continued as monotherapy as adjuvant treatment
- 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 | August 06, 2024 |
|---|---|
| Call for patient/clinician input closed | September 27, 2024 |
| Submission received | September 17, 2024 |
| Submission accepted | October 02, 2024 |
| Review initiated | October 03, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | December 18, 2024 |
| Deadline for sponsors comments | January 06, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | January 31, 2025 |
| Expert committee meeting (initial) | February 12, 2025 |
| Draft recommendation issued to sponsor | February 25, 2025 To February 27, 2025 |
| Draft recommendation posted for stakeholder feedback | March 06, 2025 |
| End of feedback period | March 21, 2025 |
Files
Last Updated : January 6, 2025