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

 
• By Sue Sutter

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.

Hurdler
PD-1/L1 sponsors successfully hurdled an FDA panel review four out of six times. • Source: Alamy

The US Food and Drug Administration’s accelerated approval process was in the spotlight for three days as its Oncologic Drugs Advisory Committee considered the future of “dangling” indications that have failed to confirm clinical benefit. While ODAC’s votes suggest that some checkpoint inhibitor indications may soon be dropped from product labeling, the expedited regulatory pathway itself is by no means in jeopardy.

Sponsors of PD-1/L1 inhibitors successfully defended four of six accelerated approvals at

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