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

27 Apr 2023

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.

Narrow opening in rocks — ODAC will consider whether AstraZeneca's proposed indication in first-line mCRPC should be narrowed to patients with tumor BRCA mutations. • Source: Shutterstock

Breadth of indication will be on the line when the US FDA’s Oncologic Drugs Advisory Committee weighs a new first-line prostate cancer claim for AstraZeneca PLC’s PARP-inhibitor Lynparza (olaparib).

In a briefing document released ahead of the 28 April meeting, the agency suggests an expanded indication for patients...