Last Updated : March 28, 2025
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 (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Enhertu (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-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 | August 06, 2024 |
|---|---|
| Call for patient/clinician input closed | September 27, 2024 |
| Submission received | September 16, 2024 |
| Clarification: Eligible for consideration as a time-limited recommendation | |
| Submission accepted | October 01, 2024 |
| Review initiated | October 02, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | December 17, 2024 |
| Deadline for sponsors comments | January 03, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | January 31, 2025 |
| Expert committee meeting (initial) | February 12, 2025 |
| Draft recommendation issued to sponsor | February 25, 2025 |
| Draft recommendation posted for stakeholder feedback | March 06, 2025 |
| End of feedback period | March 21, 2025 |
| Final recommendation issued to sponsor and drug plans | April 03, 2025 |
| Final recommendation posted | - |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | April 17, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : March 28, 2025