Accelerated Approval: US FDA Defends Size Of Premarket Safety Databases, Confirmatory Endpoints
Taking on critics who say it is too quick to award accelerated approval based on surrogate endpoints and limited safety data, agency's 25-year review shows cancer drugs receiving accelerated approval generally have twice the amount of safety data as efficacy, and more than half have confirmed clinical benefit after approval.
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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.
Pivotal Studies Supporting US FDA Drug Approvals Have Declined, JAMA Research Finds
Over 30-year period, approvals increasingly used expedited programs and were based on fewer pivotal trials with less robust comparators, authors report.
US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'
Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.