Lynparza (olaparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s029lbl.pdf. Revised September 2023. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (1)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (1)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (1)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (1)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (1)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (1)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (1)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (1)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
FDA (1)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
FDA (1)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
FDA (1)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib