Bristol Myers Squibb’s Krazati (fruquintinib) lost support as its confirmatory trial in second-line colorectal cancer failed to replicate required benefit, putting the company’s accelerated-approval pathway under risk. A company spokesperson confirmed the failure to Endpoints News. Krazati received accelerated approval in 2024 for the second-line colorectal setting, but confirmatory study underperformance can trigger regulatory consequences depending on the magnitude and nature of the lost signal. For the colorectal market, the development raises the stakes for other accelerated-approval programs and intensifies expectations for faster, cleaner confirmatory evidence to defend approvals.