JAMA Study Continues Wave Of Accelerated Approval Criticism Amid Expansion Of Pathway
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.
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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.
FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.