Last Updated : May 8, 2024
Details
Generic Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Gastric or gastroesophageal junction adenocarcinoma
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0343-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 [Combined Positive Score (CPS) 1] as determined by a validated test.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2‑positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | October 11, 2023 |
|---|---|
| Call for patient/clinician input closed | December 01, 2023 |
| Clarification: - Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada | |
| Submission received | November 22, 2023 |
| Submission accepted | - |
| Review initiated | December 07, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | February 29, 2024 |
| Deadline for sponsors comments | March 11, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | April 25, 2024 |
| Expert committee meeting (initial) | May 08, 2024 |
| Draft recommendation issued to sponsor | May 21, 2024 To May 23, 2024 |
| Draft recommendation posted for stakeholder feedback | May 30, 2024 |
| End of feedback period | June 13, 2024 |
Last Updated : May 8, 2024