olaparib


( Last Updated : August 4, 2022)
Generic Name:
olaparib
Project Status:
Received
Therapeutic Area:
gBRCAm, HER2-negative high-risk early breast cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0299-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
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.
Submission Type:
Initial
Fee Schedule:
Pending
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.
  1. 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.

Key Milestones2

Call for patient/clinician input open05-Jul-22
Call for patient/clinician input closed26-Aug-22
Submission received03-Aug-22
Submission accepted