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How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs

 
• By Sue Sutter and Nancy Pham

For the Pepaxto appeal to be wrapped up on a faster timeline than Genentech’s dispute with the US FDA drugs center over Avastin’s breast cancer claim, CBER Director Peter Marks, the commissioner’s designee, would have to render a final decision before January 2024.

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Will FDORA's expedited withdrawal procedures really address the need for speed in the cumbersome regulatory process? • Source: Shutterstock

Oncopeptides AB’s appeal of the US FDA drugs center proposal to withdraw accelerated approval for the multiple myeloma drug Pepaxto (melphalan flufenamide, or melflufen) will be the first measure of the speed offered by new expedited withdrawal procedures.

The withdrawal procedures established by the Food and Drug Omnibus Reform Act of 2022 give an accelerated approval product sponsor an opportunity for an appeal and a meeting with the...

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More from Review Pathways

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

More from Pathways & Standards

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EMA Rejects Treatments For Pediatric Myopia & CTCL

 
• By Vibha Sharma

EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.