enfortumab vedotin

Details

Files
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
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC).
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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 21, 2024
Deadline for sponsors commentsAugust 30, 2024
CADTH review report(s) and responses to comments provided to sponsorSeptember 26, 2024
Expert committee meeting (initial)October 09, 2024
Draft recommendation issued to sponsorOctober 22, 2024
To
October 24, 2024
Draft recommendation posted for stakeholder feedbackOctober 31, 2024
End of feedback periodNovember 15, 2024