pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Gastric or gastroesophageal junction (GEJ) adenocarcinoma
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0356-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Keytruda, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  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.

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Key Milestones2
Call for patient/clinician input open08-Feb-24
Call for patient/clinician input closed02-Apr-24
Clarification:

- Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada

Submission received13-Mar-24
Submission accepted28-Mar-24
Review initiated01-Apr-24
Draft CADTH review report(s) provided to sponsor for comment20-Jun-24
Deadline for sponsors comments02-Jul-24
CADTH review report(s) and responses to comments provided to sponsor01-Aug-24
Expert committee meeting (initial)14-Aug-24
Draft recommendation issued to sponsor27-Aug-24
Draft recommendation posted for stakeholder feedback05-Sep-24
End of feedback period19-Sep-24