Last Updated : March 25, 2025
Details
FilesGeneric Name:
enfortumab vedotin
Project Status:
Complete
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
- 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 | April 09, 2024 |
|---|---|
| Call for patient/clinician input closed | June 03, 2024 |
| Submission received | May 22, 2024 |
| Submission accepted | June 05, 2024 |
| Review initiated | June 06, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | August 23, 2024 |
| Deadline for sponsors comments | September 04, 2024 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | September 26, 2024 |
| Draft recommendation issued to sponsor | October 23, 2024 |
| Draft recommendation posted for stakeholder feedback | October 31, 2024 |
| End of feedback period | November 15, 2024 |
| Final recommendation issued to sponsor and drug plans | November 29, 2024 |
| Final recommendation posted | December 17, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 13, 2024 |
| CDA-AMC review report(s) posted | March 24, 2025 |
Files
Last Updated : March 25, 2025