Conflicts Galore: Upcoming Accelerated Approval Cancer Panel Includes Many Industry Relationships
US FDA issued six conflict-of-interest waivers for the Oncologic Drugs Advisory Committee’s three-day panel to consider whether indications for three immunotherapies – Tecentriq, Keytruda and Opdivo – should be withdrawn after failed clinical outcomes studies.
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After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
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.