Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Pfizer’s Tanezumab REMS Cannot Make Benefit-Risk Positive, US FDA Panel Says
Panelists say REMS would need data on long-term safety and progression of joint damage after discontinuation. In 19-1 vote, advisory committee concludes proposed Risk Evaluation and Mitigation Strategy will not ensure the anti-nerve growth factor’s modest benefits outweigh risks of joint destruction in osteoarthritis patients.
Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors
Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.
Medtech Industry Says Latest EU AI Act Revisions Insufficient As Questions Remain
Recent revisions to the European Commission’s proposed AI Act have failed to resolve uncertainties around its interaction with medtech regulations, leaving crucial parts of the legislation open to interpretation. Industry representatives have said further steps must be taken.