Last Updated : January 29, 2025
Details
FilesGeneric Name:
enfortumab vedotin
Project Status:
Complete
Therapeutic Area:
Locally advanced or metastatic urothelial carcinoma
Manufacturer:
Seagen Canada Inc.
Brand Name:
Padcev
Project Line:
Reimbursement Review
Project Number:
PC0251-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who: have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Genitourinary
Indications:
For the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum‐containing chemotherapy and programmed death receptor‐1 (PD‐1) or programmed death-ligand 1 (PD‐L1) inhibitor therapy.
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 | May 26, 2021 |
|---|---|
| Call for patient/clinician input closed | July 16, 2021 |
| Clarification: - Patient input submission received from Bladder Cancer Canada | |
| Submission received | June 23, 2021 |
| Submission accepted | July 08, 2021 |
| Review initiated | July 09, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | September 23, 2021 |
| Deadline for sponsors comments | October 04, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | October 29, 2021 |
| Expert committee meeting (initial) | November 10, 2021 |
| Draft recommendation issued to sponsor | November 23, 2021 |
| Draft recommendation posted for stakeholder feedback | December 02, 2021 |
| End of feedback period | December 16, 2021 |
| Final recommendation issued to sponsor and drug plans | January 06, 2022 |
| Final recommendation posted | January 24, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 20, 2022 |
| CADTH review report(s) posted | May 26, 2022 |
Files
Last Updated : January 29, 2025