Generic Name:
olaparib
Project Status:
Active
Therapeutic Area:
gBRCAm, HER2-negative high-risk early breast cancer
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0299-000
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Details
Manufacturer Requested Reimbursement Criteria1:
olaparib is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before Lynparza treatment is initiated.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
Lynparza (olaparib) is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before Lynparza treatment is initiated.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.