Bristol Myers Squibb’s Krazati (fruquintinib) moved into approval-risk territory after failing a confirmatory Phase 3 study in second-line colorectal cancer. The company spokesperson confirmed to Endpoints News that the confirmatory trial did not deliver the expected result, which can jeopardize the stability of accelerated approvals depending on how regulators evaluate the evidence package. The decision is especially material because Krazati previously received accelerated approval in 2024 in the same setting. A confirmatory miss can trigger label review, conversion uncertainty, or further restrictions—impacting patient access and revenue forecasts. This is a high-signal development for colorectal oncology investors watching confirmatory trial endpoints closely after accelerated approvals.