AstraZeneca’s Lynparza: US FDA Frowns Upon ‘All Comers’ Indication In First-Line Prostate Cancer

Efficacy in PROpel study was driven by the small percentage of patients with tumor BRCA mutations, agency says, raising concerns that olaparib may amount to a ‘toxic placebo’ in those without the mutation; Oncology Drugs Advisory Committee will consider whether new indication in metastatic castration-resistant prostate cancer should be restricted by mutation status.