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Accelerated Approval: US FDA Defends Size Of Premarket Safety Databases, Confirmatory Endpoints

 
• By Sue Sutter

Taking on critics who say it is too quick to award accelerated approval based on surrogate endpoints and limited safety data, agency's 25-year review shows cancer drugs receiving accelerated approval generally have twice the amount of safety data as efficacy, and more than half have confirmed clinical benefit after approval.

Medical book with Stethoscope

Safety databases for new molecular entity oncology and hematology drug indications approved under accelerated approval are, on average, twice the size of the efficacy databases, US FDA staff say in a review article published online in JAMA Oncology March 1.

The review, which takes a data-driven look at the agency's use of the accelerated approval mechanism for cancer treatments over the past 25 years, suggests that accelerated approval indications are...

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