LYNPARZA (AstraZeneca Pty Ltd)
Product name
LYNPARZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
171 working days (255)
Active ingredients
olaparib
Registration type
EOI
Indication
LYNPARZA (tablets) is now indicated as monotherapy for the treatment of adult patients with germline BRCA mutated HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Germline BRCA mutation (gBRCAm) status should be determined by an experienced laboratory using a validated test method.