Lynparza + abiraterone approved in Japan for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer – AstraZeneca + Merck Inc

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC). This approval by the Japanese Ministry of Health, Labour and Welfare was based on a subgroup analysis of the PROpel Phase III trial which showed that Lynparza plus abiraterone demonstrated highly clinically meaningful improvements in both radiographic progression-free survival (rPFS) and overall survival (OS) versus abiraterone alone in patients with BRCA mutations.

Prostate cancer is the most common cancer in men in Japan and the sixth leading cause of cancer death in the region. Despite various treatment options available, the prognosis for mCRPC remains poor, with limited options for patients whose cancer progresses following initial treatment.