Recently, AstraZeneca and Merck jointly announced that the PARP inhibitor Olaparib (trade name: Lipzol®) has been approved by the National Medical Products Administration (NMPA) as a single agent for the treatment of germline or somatic BRCA mutations (gBRCAm). Or sBRCAm) and previous treatments (including a new endocrine drug) failed in adult patients with metastatic castration-resistant prostate cancer (mCRPC).

The approval of the new indication for Olaparib is based on the research results of the global phase III clinical trial PROfound. In 2020, the New England Journal of Medicine published data from the PROfound study of Olaparib's global phase III clinical trial of mCRPC, showing that for mCRPC patients with HRR gene mutations, Olaparib can reduce imaging progression or death by 51% compared with new endocrine drugs risk. Especially in people with BRCA1/2 mutations, compared with new endocrine drugs, Olaparib single-agent efficacy is particularly excellent, which can significantly extend rPFS to 9.8 months and prolong OS to 20.1 months. And through scale evaluation, patients receiving Olaparib treatment can maintain a better quality of life.

The approval of Olaparib will bring innovative and precise treatment options for mCRPC patients with this gene mutation, and mean that BRCA gene testing may play a more important role in the diagnosis and treatment of prostate cancer in the future.