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

 
• By Sarah Karlin-Smith

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.

  • The FDA’s Richard Pazdur was clear that the agency’s previous approval of a similar drug with similar data does not mean it has to grant another sponsor the same approval if the science has changed

Bristol Myers Squibb Company seems almost certain to face the same frustration on display during the Oncologic Drugs Advisory Committee meeting for AstraZeneca’s Imfinzi (durvalumab) with its Opdivo (nivolumab)

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.