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/2020/208558s013lbl.pdf. Revised May 2020. Accessed October 6, 2026.

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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 in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 15

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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