Approval was first granted to olaparib in May 2020 and accelerated approval of rucaparib was granted in the same month. Other PARP inhibitors in development, including but not exclusively, niraparib and talazoparib have demonstrated similar efficacy in clinical studies.
Olaparib
May 2020 (FDA): For the treatment of adult patients with deleterious or suspected deleterious germline or somatic HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone; patients should be selected for therapy based on an FDA-approved companion diagnostic for olaparib.[1]
Sept 2020 (European Medicines Agency): For mCRPC with BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent [2]
Rucaparib
Accelerated approval May 2020 (FDA): For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated mCRPC who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.[3]
[1] LYNPARZA (olaparib) Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf. Accessed 22 June 2021.
[2] Lynparza Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Accessed 22 June 2021.
[3] RUBRACA (rucaparib) Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf. Accessed 22 June 2021.