CDA | Evidence Driven
CDA | Evidence Driven

enfortumab vedotin

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Generic 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.
  1. 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.
Key Milestones2
Call for patient/clinician input open09-Apr-24
Call for patient/clinician input closed03-Jun-24
Submission received22-May-24
Submission accepted05-Jun-24
Review initiated06-Jun-24
Draft CADTH review report(s) provided to sponsor for comment23-Aug-24
Deadline for sponsors comments04-Sep-24
CADTH review report(s) and responses to comments provided to sponsor26-Sep-24
Draft recommendation issued to sponsor23-Oct-24
Draft recommendation posted for stakeholder feedback31-Oct-24
End of feedback period15-Nov-24
Final recommendation issued to sponsor and drug plans28-Nov-24
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)12-Dec-24
CADTH review report(s) posted-

Files

Draft Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : November 20, 2024