pembrolizumab

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Generic 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
  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 open06-Aug-24
Call for patient/clinician input closed27-Sep-24
Submission received17-Sep-24
Submission accepted02-Oct-24
Review initiated03-Oct-24
Draft CADTH review report(s) provided to sponsor for comment18-Dec-24
Deadline for sponsors comments06-Jan-25
CADTH review report(s) and responses to comments provided to sponsor31-Jan-25
Expert committee meeting (initial)12-Feb-25
Draft recommendation issued to sponsorFebruary 25, 2025
To
February 27, 2025
Draft recommendation posted for stakeholder feedback06-Mar-25
End of feedback period21-Mar-25