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

 
• By Sarah Karlin-Smith
  
Generate a summary of this article
Listen to this article
Beta

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 Krazati letter is the third Office of Prescription Drug Promotion letter of 2024 and continues a broader trend...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Marketing & Advertising

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By Vibha Sharma

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie

 
• By Sarah Karlin-Smith

AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says. 

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.

Severe Misconduct, Repeat Offending And Underreporting: UK/EU Codes Come Under Fire

 
• By Neena Brizmohun

The UK and EU pharma industry associations have defended their respective codes of practice despite alarming study results. Meanwhile, a consultation on proposals to revise the UK code received over 3,500 comments.

More from Compliance

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 
• By Francesca Bruce

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By Vibha Sharma

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.