31 May 2023 - Today, the FDA approved olaparib (Lynparza, AstraZeneca Pharmaceuticals) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA mutated metastatic castration-resistant prostate cancer, as determined by an FDA approved companion diagnostic test.
Efficacy was evaluated in the PROpel trial that enrolled 796 patients with metastatic castration-resistant prostate cancer, patients were randomised (1:1) to receive either olaparib with abiraterone or placebo with abiraterone and also received prednisone or prednisolone.