Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Non-small cell lung cancer (NSCLC)
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0369-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda as monotherapy for the adjuvant treatment of adult patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC, and with PD-L1 tumor proportion score (TPS) less then 50% who have undergone complete resection and platinum-based chemotherapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​Keytruda as monotherapy is indicated for the adjuvant treatment of adult patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.
  1. 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.
Key Milestones2
Call for patient/clinician input open03-Jun-24
Call for patient/clinician input closed26-Jul-24
Submission received15-Jul-24
Submission accepted29-Jul-24
Review initiated30-Jul-24
Draft CADTH review report(s) provided to sponsor for comment21-Oct-24
Deadline for sponsors comments30-Oct-24
CADTH review report(s) and responses to comments provided to sponsor22-Nov-24
Expert committee meeting (initial)04-Dec-24
Draft recommendation issued to sponsor16-Dec-24
Draft recommendation posted for stakeholder feedback02-Jan-25
End of feedback period16-Jan-25
Final recommendation issued to sponsor and drug plans30-Jan-25
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)13-Feb-25
CADTH review report(s) posted-

Files

Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : January 20, 2025