CHMP recommends Lynparza to treat metastatic castration-resistant prostate cancer with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations.- AstraZeneca + Merck Inc.

AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial. The primary results from the trial were published in The New England Journal of Medicine in May 2020. Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3 million new patients diagnosed worldwide in 2018. Approximately 12% of men with mCRPC have a BRCA mutation.he CHMP recommendation for Lynparza is for the treatment of adult patients with mCRPC and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.