Last Updated : February 25, 2025
Details
FilesGeneric 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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.
| Call for patient/clinician input open | May 14, 2024 |
|---|---|
| Call for patient/clinician input closed | July 08, 2024 |
| Submission received | June 28, 2024 |
| Submission accepted | July 15, 2024 |
| Review initiated | July 16, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | October 21, 2024 |
| Deadline for sponsors comments | October 30, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | November 22, 2024 |
| Expert committee meeting (initial) | December 04, 2024 |
| Draft recommendation issued to sponsor | December 17, 2024 |
| Draft recommendation posted for stakeholder feedback | January 02, 2025 |
| End of feedback period | January 16, 2025 |
| Final recommendation issued to sponsor and drug plans | January 29, 2025 |
| Final recommendation posted | February 14, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 12, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 25, 2025