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Misconstruing Single-Arm Study Data Lands BMS In Trouble With US FDA

 
• By Sarah Karlin-Smith

The lung cancer drug Krazati from Bristol Myers Squibb’s Mirati Therapeutics drew an FDA ad/promo untitled letter, highlighting the agency's trend of pursuing false or misleading efficacy claims, particularly when data comes from outside approved labeling.

doctor that appears to be "holding" lungs
The BMS lung cancer drug was the subject of the FDA's third OPDP letter of the year. • Source: Shutterstock

Bristol Myers Squibb Company’s Mirati Therapeutics, Inc. landed a US Food and Drug Administration untitled letter for the health care provider website of its lung cancer drug Krazati (adagrasib) due to repeated misrepresentations of data from a single-arm study and use of off-label data the FDA could not verify.

Key Takeaways

  • The FDA untitled letter dings BMS for making claims about its lung cancer drug that are not supported by the single-arm trial cited.

  • The...

The Krazati letter is the third Office of Prescription Drug Promotion letter of 2024 and continues a broader trend of the FDA pursuing false or misleading misrepresentations of efficacy...

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