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US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

 
• By Sue Sutter

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

Cancelled sign
Since October, the FDA has cancelled ODAC reviews of accelerated approval drugs Farydak, Marqibo and Pepaxto. • Source: Alamy

The US Food and Drug Administration has cancelled advisory committee reviews of two accelerated approval cancer drugs for which confirmation of clinical benefit is overdue.

The Oncologic Drugs Advisory Committee was scheduled to meet 2 December to discuss the future of Secura Bio, Inc.’s multiple myeloma drug Farydak (panobinostat) and Acrotech Biopharma...

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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EU CHMP Opinions And MAA Updates

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.