Akeega (Janssen), a fixed-dose combination of the oral poly(ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula) and the antiandrogen abiraterone acetate (Zytiga, and others), has been approved by the FDA for use in combination with prednisone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Niraparib has been available since 2017 for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. Abiraterone acetate has been available since 2011 for treatment of CRPC and castration-sensitive prostate cancer (CSPC).

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has now been approved by the FDA for use in combination with abiraterone (Zytiga, and others) and either prednisone or prednisolone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib was previously approved by the FDA for treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombinant repair (HRR) genemutated mCRPC who progressed on prior treatment with enzalutamide (Xtandi) or abiraterone.

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

The FDA has approved enzalutamide (en za loo’ ta mide; Xtandi – Astellas/Medivation) for oral treatment of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and generics). It is the second oral drug approved for this indication; abiraterone acetate (Zytiga), which is also approved for first-line use, was the first. Cabazitaxel (Jevtana), which is given parenterally, has a similar indication.

The FDA has approved abiraterone acetate (Zytiga – Centocor Ortho Biotech) for oral treatment, in combination with prednisone, of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and others). It is the first oral drug approved for this indication. Zytiga will compete with cabazitaxel (Jevtana) and sipuleucel-T (Provenge).