enfortumab vedotin

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Generic 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:
  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 openApril 09, 2024
Call for patient/clinician input closedJune 03, 2024
Submission receivedMay 22, 2024
Submission acceptedJune 05, 2024
Review initiatedJune 06, 2024
Draft CADTH review report(s) provided to sponsor for commentAugust 23, 2024
Deadline for sponsors commentsSeptember 04, 2024
CADTH review report(s) and responses to comments provided to sponsorSeptember 26, 2024
Draft recommendation issued to sponsorOctober 23, 2024
Draft recommendation posted for stakeholder feedbackOctober 31, 2024
End of feedback periodNovember 15, 2024
Final recommendation issued to sponsor and drug plansNovember 29, 2024
Final recommendation postedDecember 17, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 13, 2024
CADTH review report(s) postedMarch 24, 2025