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FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials

 
• By Sue Sutter

Confirmatory trials for anti-cancer drugs should be targeted for completion no later than two to four years after accelerated approval is granted, agency says, offering various strategies and factors sponsors should consider to ensure they are conducting studies with due diligence.

Hammer
FDA may be more willing to bring down the hammer on oncology accelerated approval drug sponsors who fail to conduct their confirmatory trials with due diligence. • Source: Shutterstock

A US Food and Drug Administration advisory committee review of two Acrotech Biopharma LLC accelerated approval drugs with long-overdue confirmatory trial requirements may provide the clearest insight yet into how the Oncology Center of Excellence interprets the “due diligence” requirement for such studies and how sponsors’ planning and implementation strategies may factor into this determination.

The Oncologic Drugs Advisory Committee on 16 November will not only review Acrotech’s current confirmatory trial plan for the peripheral T-cell lymphoma drugs Folotyn (pralatrexate) and Beleodaq (belinostat), but it...

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More from US FDA Performance Tracker

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

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

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

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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.

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

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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.

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.