Last Updated : July 29, 2025
Details
FilesGeneric Name:
talazoparib
Project Status:
Active
Therapeutic Area:
Metastatic castration-resistant prostate cancer
Manufacturer:
Pfizer Canada ULC
Call for patient/clinician input open:
Brand Name:
Talzenna
Project Line:
Reimbursement Review
Project Number:
PC0417-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Submission Type:
Initial
Submission Complexity:
Standard Review
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
In combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated 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 | February 13, 2025 |
|---|---|
| Call for patient/clinician input closed | April 07, 2025 |
| Submission received | March 27, 2025 |
| Submission accepted | April 10, 2025 |
| Review initiated | April 11, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | July 18, 2025 |
| Deadline for sponsors comments | July 29, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | August 28, 2025 |
| Expert committee meeting (initial) | September 10, 2025 |
| Draft recommendation issued to sponsor | September 22, 2025 To September 24, 2025 |
| Draft recommendation posted for stakeholder feedback | October 02, 2025 |
| End of feedback period | October 17, 2025 |
Files
Last Updated : July 29, 2025