New FDA Advisory Cmte. Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith
  
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Recent ODACs suggest FDA is moving towards focusing not just on applications with pending approval decisions but on refining trials designs and drug labels for their competitors as well.

Competitor applicants have recently been putting previously approved drugs back in advisory committee spotlight.

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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