Bristol Myers Squibb’s Krazati failed its confirmatory trial in second-line colorectal cancer, raising uncertainty about the therapy’s regulatory status. The company confirmed the failure to Endpoints News, noting the confirmatory study outcome in a setting where Krazati had previously received accelerated approval in 2024. The reporting indicates the confirmatory result undermines the confirmatory evidence base that regulators typically require to maintain accelerated approvals. As a result, Krazati’s forward path may depend on how BMS and regulators handle confirmatory data and any subsequent submissions or analysis. The outcome illustrates the execution risk in accelerated-approval-to-confirmatory study transitions for oncology programs, especially where endpoint performance must replicate earlier signal.