The accelerated pathway is intended for drugs that treat serious conditions and fill an unmet medical need in US. Approval is based on a surrogate or an early clinical endpoint and is conditional on the completion of confirmatory trials, which are planned prior to the approval process.
An editorial suggests the following three improvements to the accelerated pathway for cancer drug approvals:
• Confirmatory postmarketing studies for accelerated drug approvals should include both overall survival (OS) and quality of life (QoL) outcomes
• Preapproved QoL measures should be published for specific drug classes.
• Anticipated or clinically significant changes in OS and in QoL measures should be defined a priori to facilitate the identification of drugs whose “postmarketing clinical study fails to verify clinical benefit.”
It concludes “the FDA should promptly withdraw approval for cancer drugs that are proven to have no clinical benefit. Removing these drugs, each of which costs between $20 000 and $170 000 per year, from the market will improve the quality and value of cancer care.”