talazoparib

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).
  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 openJuly 04, 2023
Call for patient/clinician input closedAugust 25, 2023
Clarification:

- Patient input submission received from Canadian Cancer Society

Submission receivedAugust 15, 2023
Submission acceptedAugust 29, 2023
Review initiatedAugust 30, 2023
Draft CADTH review report(s) provided to sponsor for commentNovember 16, 2023
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Deadline for sponsors commentsDecember 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-