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/2023/208558s025lbl.pdf. Revised May 2023. 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 abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. 8

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 Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisolone
FDA (1) BRCA1 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisolone
FDA (1) BRCA2 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisolone
FDA (1) BRCA2 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisolone
FDA (1) BRCA1 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisone
FDA (1) BRCA1 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisone
FDA (1) BRCA2 oncogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisone
FDA (1) BRCA2 pathogenic variants Prostate Adenocarcinoma Abiraterone acetate, Olaparib, Prednisone