Therapeutic Response

BRCA2 pathogenic variants status confers therapeutic sensitivity to Olaparib in patients with Prostate Adenocarcinoma.

Statements

Source and description
Lynparza (olaparib) [package insert]. FDA.

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.
Lynparza (olaparib) [product information]. EMA.

The European Medicines Agency (EMA) has authorized olaparib as a monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy treatment option for the treatment of adult patients with metastatic castration-resistant prostate cancer whose tumors harbor BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.