BMS's Krazati fails confirmatory colorectal cancer trial, jeopardizing its accelerated approval

Bristol Myers Squibb said its drug Krazati did not meet the primary endpoint in a confirmatory study for second‑line colorectal cancer.

The trial was required to verify the benefit that earned the drug accelerated approval in 2024, and the negative result puts that conditional approval at risk of being withdrawn or not converted to full approval.

BMS indicated it will analyze the data further and engage with regulators to determine next steps, a development that could impact investors and the competitive landscape for colorectal cancer treatments.