FDA debated on briefing documents released ahead of an advisory committee meeting that Lynparza has only shown a favorable benefit-risk profile in patients with BRCA mutations in metastatic castration-resistant prostate cancer (mCRPC)

In all patients without BRCA mutations, the reviewers flagged a modest benefit and possible harm

Based on sNDA which FDA accepted in Aug 2022 Merck and AstraZeneca supported Lynparza’s FDA bid with data from the Phase III PROpel study

In the FDA’s analysis, the Lynparza combo was linked to a 6% increased risk of death as patients who got it lived a median of 37 months, versus 38 months for the Zytiga arm