Evaluating Food and Drug Administration approved gastrointestinal cancer drugs: clinical benefit and trial endpoints over the past two decades.

We found an increasing trend in accelerated GI cancer treatment approvals, with 31.1% occurring after 2015 compared to only 6.7% before 2015. 1 Unlike regular approvals, accelerated approvals require postmarketing surveillance, 44 and the FDA has the authority to withdraw a drug if confirmatory trials are not conducted or fail to demonstrate benefits. 6 While awaiting the confirmatory trials, patients may be subjected to unnecessary toxicities from cancer treatments that are approved under the accelerated pathway.

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