Current landscape of US Food and Drug Administration use of expedited regulatory approvals for colorectal cancer care

ERPs have expedited approvals for new and increasingly targeted CRC treatments. All CRC treatments approved through Accelerated Approval or Breakthrough Therapy Designation after 2018 still await confirmatory trial results. These findings highlight the complexity of available drugs and diagnostic tests and the challenges facing managed care pharmacists in formulary management, diagnostic test coordination, and the development of utilization criteria given limited long-term clinical evidence.