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.

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Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
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