New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith
  
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Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

empty dark stage with a spotlight on the center
Competitor applicants recently have put previously approved drugs back in the advisory committee spotlight. (Shutterstock)

For the second time in recent months the US Food and Drug Administration is convening an Oncologic Drugs Advisory Committee that is using the presence of a pending application to debate whether changes are needed to the broader field of drugs in the same class and indication.

Key Takeaways

  • For the second time in recent months FDA is using a cancer drug advisory committee to weigh broader class-wide changes, not just a pending application.

Such a move should put sponsors on notice that their medications may catch the FDA’s advisory committee spotlight when they...

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