pembrolizumab

Details

Generic Name:
pembrolizumab
Project Status:
Received
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:
Pending
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) å1] as determined by a validated test.
  1. 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.
Key Milestones2
Call for patient/clinician input open11-Oct-23
Call for patient/clinician input closed01-Dec-23
Submission received22-Nov-23
Submission accepted