LYNPARZA (AstraZeneca Pty Ltd)
Product name
LYNPARZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
225 (255 working days)
Active ingredients
olaparib
Registration type
EOI
Indication
LYNPARZA (tablet) in combination with bevacizumab is now also indicated for the:
- maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:
- a deleterious or suspected deleterious BRCA mutation (germline or somatic), and/or
- genomic instability
HRD status should be determined by an experienced laboratory using a validated test method.
Adenocarcinoma of the pancreas
LYNPARZA is now also indicated as monotherapy for the:
- maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Germline BRCA mutation (gBRCAm) status should be determined by an experienced laboratory using a validated test method.