Last Updated : October 22, 2024
Details
FilesGeneric Name:
trastuzumab deruxtecan
Project Status:
Active
Therapeutic Area:
Gastric or gastroesophageal junction (GEJ) adenocarcinoma
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Enhertu
Project Line:
Reimbursement Review
Project Number:
PC0367-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Enhertu as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Enhertu as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen.
- 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 | 06-Aug-24 |
|---|---|
| Call for patient/clinician input closed | 27-Sep-24 |
| Submission received | 16-Sep-24 |
| Clarification: Eligible for consideration as a time-limited recommendation | |
| Submission accepted | 01-Oct-24 |
| Review initiated | 02-Oct-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 17-Dec-24 |
| Deadline for sponsors comments | 03-Jan-25 |
| CADTH review report(s) and responses to comments provided to sponsor | 31-Jan-25 |
| Expert committee meeting (initial) | 12-Feb-25 |
| Draft recommendation issued to sponsor | February 25, 2025 To February 27, 2025 |
| Draft recommendation posted for stakeholder feedback | 06-Mar-25 |
| End of feedback period | 21-Mar-25 |
Files
Last Updated : October 22, 2024