FDA Accuses BMS of Misleading Data on Krazati

The FDA has charged Bristol Myers Squibb for fabricating or misrepresenting information on its website regarding Krazati's effectiveness as a treatment for KRAS cancer. Krazati received expedited approval in KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. It was purchased in a $5.8 billion buyout of Mirati Therapeutics. BMS provided trial data supporting authorisation on the Krazati website's efficacy page targeted at medical professionals. The FDA has objected to the efficacy page, as have several other complainants.

The Office of Prescription Drug Promotion at the FDA brought attention to the alleged issues with the various effectiveness metrics provided on the Krazati website. The website's disease control rate (DCR) feature displays a waterfall graphic and reports that 80% of patients had tumour shrinking of any size. The DCR data presentation, which includes the ORR and stable disease rate, was deemed inadequate by the FDA.

BMS was also charged by the FDA with providing false information on overall and progression-free survival. Time-to-event effectiveness endpoints in single-arm studies, according to the FDA, are typically uninterpretable since it is impossible to distinguish between the drug's and the disease's natural history as the source of the observed effect (such as survival time). Notification from BMS that the survival analyses are "descriptive"failed to save it from the FDA's ire.

The FDA wrapped up its analysis of the website by listing all of its problems, including a page detailing the intracranial ORR and DCR seen in the research. The results may be due to the effects of the radiation therapy that was previously administered to the majority of the patients in the investigation, rather than Krazati.