AstraZeneca's Olaparib Tablet Nears Approval in China for New Prostate Cancer Indication

On June 7, the official website of China's National Medical Products Administration (NMPA) indicated that AstraZeneca's marketing authorization application for a new indication of olaparib tablets (Acceptance No.: JXHS2100001) has entered the "under review" stage and is expected to receive NMPA approval in the near future. The indication likely to be approved is for monotherapy in adult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations (germline and/or somatic) who have experienced disease progression following prior novel hormonal therapy.