Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Conflicts Galore: Upcoming Accelerated Approval Cancer Panel Includes Many Industry Relationships

Executive Summary

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three-day panel to consider whether indications for three immunotherapies – Tecentriq, Keytruda and Opdivo – should be withdrawn after failed clinical outcomes studies.

You may also be interested in...



US FDA Advisory Committee Reboot (Part II): The Right Balance For Conflicts Of Interest

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.

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144196

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel