BMS Faulted for Making Inaccurate Claims

The FDA rebuked Bristol Myers Squibb (BMS) for making false and misleading statements on a website for health care providers describing the benefits of adagrasib (Krazati), a KRAS^G12C inhibitor, STAT reported. In a letter to BMS, the agency noted that the site claims the drug improves the disease control rate (DCR) and depth of response in patients with KRAS^G12C-mutated non–small cell lung cancer. However, the trial that led to adagrasib’s accelerated approval was not designed to assess these endpoints; rather, the single-arm KRYSTAL-1 study evaluated the objective response rate and duration of response. It did not establish that stable disease, which BMS used when calculating the DCR and associated with the depth of response, could be linked to the drug. The FDA directed BMS to respond to the letter within 15 business days.