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ODAC Report Card: Six Takeaways From Accelerated Approval Reviews Of Checkpoint Inhibitors

Executive Summary

US FDA’s expedited pathway remains alive and well in oncology, but ‘dangling’ indications may be subject to more regular public scrutiny going forward; negative votes for two of six indications reflected the influence of Oncology Center of Excellence director Richard Pazdur.

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Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

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.

Istodax’s Lymphoma Accelerated Approval Indication Falls Victim To Failed Confirmatory Trial

BMS’ histone deacetylase inhibitor is the first oncology drug outside the PD-1/L1 class to lose an indication under US FDA’s recent review of ‘dangling’ accelerated approvals. Claim for second-line peripheral T-cell lymphoma was withdrawn because first-line study failed to meet its progression-free survival endpoint.

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