CDA | Evidence Driven
CDA | Evidence Driven

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:
TBC
Project Line:
Reimbursement Review
Project Number:
PC0338-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Zolbetuximab, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of 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:
​Zolbetuximab, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of 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 sponsorDecember 16, 2024
To
December 18, 2024
Draft recommendation posted for stakeholder feedback02-Jan-25
End of feedback period16-Jan-25

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Patient and Clinician Group Input View PDF
Last Updated : October 31, 2024