Last Updated : September 4, 2024
Details
FilesGeneric Name:
enfortumab vedotin
Project Status:
Active
Therapeutic Area:
Metastatic urothelial cancer
Manufacturer:
Seagen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Padcev
Project Line:
Reimbursement Review
Project Number:
PC0353-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with pembrolizumab, is indicated for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC.
- 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 | 09-Apr-24 |
|---|---|
| Call for patient/clinician input closed | 03-Jun-24 |
| Submission received | 22-May-24 |
| Submission accepted | 05-Jun-24 |
| Review initiated | 06-Jun-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Aug-24 |
| Deadline for sponsors comments | 04-Sep-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 26-Sep-24 |
| Expert committee meeting (initial) | 09-Oct-24 |
| Draft recommendation issued to sponsor | October 22, 2024 To October 24, 2024 |
| Draft recommendation posted for stakeholder feedback | 31-Oct-24 |
| End of feedback period | 15-Nov-24 |
Files
Last Updated : September 4, 2024