Last Updated : September 12, 2024
Details
Generic Name:
talazoparib
Project Status:
Suspended
Therapeutic Area:
Metastatic castration-resistant prostate cancer (mCRPC)
Manufacturer:
Pfizer Canada ULC
Call for patient/clinician input open:
Brand Name:
Talzenna
Project Line:
Reimbursement Review
Project Number:
PC0316-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with enzalutamide, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with enzalutamide, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
- 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 | July 04, 2023 |
|---|---|
| Call for patient/clinician input closed | August 25, 2023 |
| Clarification: - Patient input submission received from Canadian Cancer Society | |
| Submission received | August 15, 2023 |
| Submission accepted | August 29, 2023 |
| Review initiated | August 30, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | November 16, 2023 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Deadline for sponsors comments | December 06, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | - |
| Clarification: - Submission temporarily suspended | |
| Expert committee meeting (initial) | - |
| Draft recommendation issued to sponsor | - |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Last Updated : September 12, 2024