BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push

 
• By Sarah Karlin-Smith
  
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AstraZeneca’s Imfinzi lung cancer advisory panel, which offered insight into why sponsors do not always follow agency advice, likely is a preview of the hurdle facing Bristol Myers Squibb’s Opdivo application for the same indication. 

two sets of business people with giant speaking bubbles that are disconnected and broken showing visual of communication breakdown
The Imfinzi ODAC meeting revealed potentially broader communication problems between the FDA and industry. • Source: Shutterstock

The US Food and Drug Administration's cancer leadership appeared visibly frustrated 25 July that AstraZeneca PLC submitted a perioperative drug application that did not follow the agency’s six-year-old advice to characterize the contribution of each phase of therapy.

Key Takeaways

  • AstraZeneca’s Imfinzi adcomm suggested the company and FDA seem to have different opinions of when the agency is suggesting versus requiring a sponsor to do something.

Bristol Myers Squibb Company seems almost certain to face the same frustration on display during the Oncologic Drugs Advisory...

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