Skip to Content

Lynparza Approval History

FDA Approved: Yes (First approved December 19, 2014)
Brand name: Lynparza
Generic name: olaparib
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for the treatment of BRCA-mutated, advanced ovarian cancer; for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; and for the treatment of germline BRCA-mutated metastatic breast cancer.

Development History and FDA Approval Process for Lynparza

Dec 19, 2018Approval Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
Jan 12, 2018Approval FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
Aug 17, 2017Approval FDA Approves Tablet Formulation of Lynparza (olaparib) for Maintenance Treatment of Ovarian Cancer
Jun  4, 2017Lynparza (olaparib) Significantly Reduces the Risk of Disease Worsening or Death in Patients with BRCA-Mutated Metastatic Breast Cancer
Dec 19, 2014Approval FDA Approves Lynparza (olaparib) to Treat Advanced Ovarian Cancer
Jun 25, 2014FDA Advisory Committee Votes on Accelerated Approval for Investigational Medicine Olaparib

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.