LYNPARZA (AstraZeneca Pty Ltd)
Product name
LYNPARZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
104 working days (255)
Active ingredients
olaparib
Registration type
EOI
Indication
Ovarian Cancer
LYNPARZA (film coated tablets) is now also indicated as monotherapy for the:
- maintenance treatment of adult patients with advanced BRCA-mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. BRCA mutation status should be determined by an experienced laboratory using a validated test method.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available