Table 5. Approval status of olaparib and rucaparib for prostate cancer.

Indications for Olaparib United States: Treatment for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated CRPC who have progressed following treatment with enzalutamide or abiraterone. United Kingdom: As 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. Canada: As monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated mCRPC who have progressed following prior treatment with a new hormonal agent. BRCA or ATM mutations must be confirmed before olaparib treatment is initiated. India: Treatment of patients with mCRPC and HRR gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.

Indications for Rucaparib United States: Treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated mCRPC who have been treated with androgen receptor directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response.

Abbreviations: BRCA: breast cancer gene; HRR: homologous recombination repair; mCPRC: metastatic castrate-resistant prostate cancer.