Canada’s Drug Agency | Drugs, Health Technologies and Systems.

talazoparib

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Generic 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
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).
  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 open13-Feb-25
Call for patient/clinician input closed07-Apr-25
Submission received27-Mar-25
Submission accepted10-Apr-25
Review initiated11-Apr-25
Draft CADTH review report(s) provided to sponsor for comment27-Jun-25
Deadline for sponsors comments09-Jul-25
CDA-AMC review report(s) and responses to comments provided to sponsor28-Aug-25
Expert committee meeting (initial)10-Sep-25
Draft recommendation issued to sponsorSeptember 22, 2025
To
September 24, 2025
Draft recommendation posted for stakeholder feedback02-Oct-25
End of feedback period17-Oct-25

Files

Patient and Clinician Group Input View PDF
Last Updated : April 14, 2025