Lynparza Approval History

FDA Approved: Yes (First approved December 19, 2014)
Brand name: Lynparza
Generic name: olaparib
Dosage form: Capsules and 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.

Lynparza capsules (discontinued) and tablets are indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Lynparza tablets are indicated for:

• the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy
• the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
• the treatment of breast cancer in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

Lynparza capsules were permanently discontinued from the U.S. market on August 31, 2018.

Development History and FDA Approval Process for Lynparza

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

Further information

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