LYNPARZA (AstraZeneca Pty Ltd)
Product name
LYNPARZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
226 (255 working days
Active ingredients
olaparib
Registration type
EOI
Indication
Breast cancer
LYNPARZA is indicated as monotherapy for the:
adjuvant treatment of adult patients who have HER2-negative, high-risk early breast cancer with a deleterious or suspected deleterious germline BRCA mutation (gBRCAm), for which they have previously been treated with neoadjuvant or adjuvant chemotherapy.
Prostate cancer
LYNPARZA in combination with abiraterone and either prednisone or prednisolone is indicated for the:
treatment of adult patients who have mCRPC with a deleterious or suspected deleterious BRCA mutation (germline or somatic).