Last Updated : January 20, 2023
Details
FilesGeneric Name:
Olaparib
Project Status:
Complete
Therapeutic Area:
metastatic castration-resistant prostate cancer (mCRPC)
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0223-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As monotherapy for the treatment of adult patients with mCRPC and deleterious or suspected deleterious germline and/or somatic mutations in the HRR genes BRCA or ATM who have progressed following prior treatment with a NHA. treatment with a new hormonal agent (NHA).
Companion Diagnostics:
Yes
Fee Schedule:
Pending
Strength:
100 mg and 150 mg
Tumour Type:
Genitourinary
Indications:
As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene mutations (germline and/or somatic) who have progressed following prior treatment with a new hormonal agent (NHA).
Funding Request:
As monotherapy for the treatment of adult patients with mCRPC and deleterious or suspected deleterious germline and/or somatic mutations in the HRR genes BRCA or ATM who have progressed following prior treatment with a NHA.
Review Status:
Notification to Implement Issued
Sponsor:
AstraZeneca Canada Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:
- 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.
Files
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Last Updated : January 20, 2023