Last Updated : June 6, 2024
Details
FilesGeneric Name:
relugolix
Project Status:
Active
Therapeutic Area:
Advanced prostate cancer
Manufacturer:
Sumitomo Pharma Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Orgovyx
Project Line:
Reimbursement Review
Project Number:
PC0342-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with advanced prostate cancer.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with advanced prostate cancer.
- 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.
Call for patient/clinician input open | September 29, 2023 |
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Call for patient/clinician input closed | November 27, 2023 |
Clarification: - Patient input submission received from The Androgen Deprivation Therapy Education Program, the Canadian Cancer Society and PROCURE - CANCER PROSTATE | |
Submission received | November 14, 2023 |
Submission accepted | November 28, 2023 |
Review initiated | November 29, 2023 |
Draft CADTH review report(s) provided to sponsor for comment | February 23, 2024 |
Deadline for sponsors comments | March 05, 2024 |
CADTH review report(s) and responses to comments provided to sponsor | March 28, 2024 |
Expert committee meeting (initial) | April 10, 2024 |
Draft recommendation issued to sponsor | April 23, 2024 |
Draft recommendation posted for stakeholder feedback | May 02, 2024 |
End of feedback period | May 16, 2024 |
Clarification: - Reconsideration: minor revisions requested by drug programs - Request for reconsideration accepted |
Files
Last Updated : June 6, 2024