FDA Panel Votes for Limited Approval of AstraZeneca and Merck’s Lynparza

May 1, 2023

AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and J&J’s Zytiga only for a small subset of mCRPC patients.

According to Angus Liu, “In its review, the FDA focused on a subgroup of patients who were confirmed to not have BRCA mutations through two tests measuring either plasma circulating tumor DNA or tissue samples. In this subgroup of patients, who made up 54% of the PROpel trial, the Lynparza regimen reduced the risk of progression or death by 15% but was linked to a 6% increase in death risk, according to a post-hoc analysis. Pointing to what it viewed as a “modest” tumor progression benefit but a potential detriment to patient survival, the FDA argued that an approval for the Lynparza-Zytiga combo should be restricted to BRCA-mutant patients.”

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