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

zolbetuximab

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Generic Name:
zolbetuximab
Project Status:
Active
Therapeutic Area:
Gastric or gastroesophageal junction (GEJ) adenocarcinoma
Manufacturer:
Astellas Pharma Canada, Inc. (APCA)
Call for patient/clinician input open:
Brand Name:
Vyloy
Project Line:
Reimbursement Review
Project Number:
PC0338-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Vyloy (zolbetuximab for injection), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive as determined by a validated test.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Vyloy (zolbetuximab for injection), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive as determined by a validated test.
  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 open14-May-24
Call for patient/clinician input closed08-Jul-24
Submission received28-Jun-24
Submission accepted15-Jul-24
Review initiated16-Jul-24
Draft CADTH review report(s) provided to sponsor for comment21-Oct-24
Deadline for sponsors comments30-Oct-24
CADTH review report(s) and responses to comments provided to sponsor22-Nov-24
Expert committee meeting (initial)04-Dec-24
Draft recommendation issued to sponsor17-Dec-24
Draft recommendation posted for stakeholder feedback02-Jan-25
End of feedback period16-Jan-25
Final recommendation issued to sponsor and drug plans29-Jan-25
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)12-Feb-25
CADTH review report(s) posted-

Files

Draft Recommendation View PDF
Patient and Clinician Group Input View PDF
Last Updated : January 20, 2025