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.

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...

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