FDA Questions Efficacy of Merck-AstraZeneca’s Lynparza Ahead of Adcomm

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2. The pharma partners aim to broaden Lynparza's indication in combination with Zytiga and prednisone.

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3. In their sNDA, Merck and AstraZeneca presented data from the Phase III PROpel study.

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4. Lynparza-treated patients saw a 34% drop in progression or death risk, compared to placebo-based regimen.

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5. Median progression-free survival in the Lynparza arm was 24.8 months, versus 16.6 months in placebo comparators.

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6. FDA awarded the sNDA a Priority Review designation, but later postponed the target action date.

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7. An ODAC meeting is set to discuss the merits of Lynparza's sNDA and assess its risk-benefit profile.

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8. FDA's briefing package highlighted a "significant design flaw" in the PROpel study.

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9. The FDA found Lynparza's benefits could be heavily attributed to its effects in the BRCA mutation subgroup.

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10. The FDA expressed concerns about the risk:benefit tradeoff and potential overall survival detriment in patients with tumor BRCA mutation.

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