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

pembrolizumab

Details

Files
Generic Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Cervical cancer
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0411-000
Call for patient/clinician input closed:
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Pembrolizumab for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy (CRT).
  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 open10-Feb-25
Call for patient/clinician input closed07-Apr-25
Submission received25-Mar-25
Submission accepted08-Apr-25
Review initiated09-Apr-25
Draft CADTH review report(s) provided to sponsor for comment25-Jun-25
Deadline for sponsors comments07-Jul-25
CDA-AMC review report(s) and responses to comments provided to sponsor31-Jul-25
Expert committee meeting (initial)13-Aug-25
Draft recommendation issued to sponsorAugust 25, 2025
To
August 27, 2025
Draft recommendation posted for stakeholder feedback04-Sep-25
End of feedback period18-Sep-25

Files

Patient and Clinician Group input View PDF
Last Updated : April 23, 2025