FDA Criticizes Bristol Myers Squibb for Misleading Efficacy Claims on Krazati Website

FDA Action:
The FDA has issued a letter to Bristol Myers Squibb (BMS) criticizing the company for making false and misleading claims about the efficacy of Krazati, a treatment for non-small-cell lung cancer (NSCLC).

Misleading Claims:
The FDA noted that the claims on the Krazati website were based on a study that was not designed to support such representations. The study was a single-arm trial, which cannot definitively attribute the results to the treatment.

Regulatory Violations:
The FDA stated that the website misbrands Krazati under the Federal Food, Drug, and Cosmetic Act (FD&C Act), making its distribution violative.

Serious Health Concerns:
NSCLC is a serious public health concern with a low 5-year survival rate, and the FDA emphasized the importance of accurate information for treatments.

Complaints Received:
The FDA's Bad Ad Program received multiple complaints regarding the misleading claims on the Krazati website.

Accelerated Approval:
Krazati was approved under the accelerated approval pathway, which allows for earlier approval based on surrogate endpoints, contingent upon verification of clinical benefit in confirmatory trials.

Adverse Reactions:
The prescribing information for Krazati includes warnings for gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease/pneumonitis.