Cancer Accelerated Approval On Trial: Advisors With Conflict-Of-Interest Waivers More Likely To Support Industry
US FDA Oncologic Drugs Advisory Committee panelists who were granted financial conflict-of-interest waivers to participate in the agency’s multi-day review of accelerated approvals for three immunotherapies voted in favor of keeping the indications at issue on market more than three-quarters of the time. Non-conflicted experts voted in favor only two-thirds of the time. One of the six panel outcomes would have been different without the conflicted members’ votes.
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Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.
Bladder Cancer Accelerated Approvals: Merck, Genentech PD-1/L1 Inhibitors Prevail At US FDA Panel, But For Different Reasons
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