Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors
Executive Summary
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.
You may also be interested in...
Roche Withdraws Tecentriq’s Frontline Bladder Cancer Indication, Ceding Market To Keytruda
The move marks the second time since last year that Roche has withdrawn a urothelial carcinoma indication after its confirmatory trial failed to show an overall survival benefit.
Failed Confirmatory Trial Won’t Force Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says
Jazz/PharmaMar’s SCLC drug will stay on the market while two more trials with different designs are conducted after confirmatory trial did not meet overall survival endpoint. Citizen petition requesting agency withdraw lurbinectedin underscores vagaries of accelerated approval.
Keytruda's Urothelial Cancer Claim Goes From Accelerated To Full Approval, With More Limited Scope
US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.