Lynparza (olaparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.

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 advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	12
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
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.	12
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	2
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	2
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	2
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	28
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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (2)	BRCA1 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (2)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (2)	BRCA2 oncogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (2)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Olaparib
FDA (2)	BRCA1 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (2)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (2)	BRCA2 oncogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (2)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Olaparib
FDA (2)	BRCA1 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
FDA (2)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
FDA (2)	BRCA2 oncogenic variants	Peritoneal Serous Carcinoma	Olaparib
FDA (2)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Olaparib
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
FDA (2)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
FDA (2)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Olaparib
FDA (1)	BRCA1 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
FDA (1)	BRCA2 pathogenic variants	Pancreatic Adenocarcinoma	Olaparib
FDA (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	ATM pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	ATM oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BARD1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BARD1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BRIP1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	BRIP1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	CDK12 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	CDK12 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	CHEK1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	CHEK1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	CHEK2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	CHEK2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	FANCL pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	FANCL oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	PALB2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	PALB2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD51B pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD51B oncogenic variants	Prostate Adenocarcinoma	Talazoparib
FDA (1)	RAD51C pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD51C oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD51D pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD51D oncogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD54L pathogenic variants	Prostate Adenocarcinoma	Olaparib
FDA (1)	RAD54L oncogenic variants	Prostate Adenocarcinoma	Olaparib
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