Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to olaparib 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. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRCA2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	ATM pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	ATM oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BARD1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BARD1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRIP1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	BRIP1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	CDK12 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	CDK12 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	CHEK1 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	CHEK1 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	CHEK2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	CHEK2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	FANCL pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	FANCL oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	PALB2 pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	PALB2 oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD51B pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD51B oncogenic variants	Prostate Adenocarcinoma	Talazoparib
Sensitivity (+)	RAD51C pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD51C oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD51D pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD51D oncogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD54L pathogenic variants	Prostate Adenocarcinoma	Olaparib
Sensitivity (+)	RAD54L oncogenic variants	Prostate Adenocarcinoma	Olaparib