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