‘Dangling’ Accelerated Approval Reviews Expand At US FDA

The US Food & Drug Administration’s Oncologic Drugs Advisory Committee is slated to review the status of three more Accelerated Approval marketing applications over the course of the fall – but only two of three should be considered as part of the broader effort to address so-called “dangling” approvals.

ODAC met in April to discuss six indications for checkpoint inhibitors where confirmatory trials have not yet demonstrated clear clinical benefit. That meeting was a kick-off effort for the Oncology...