Accelerated Approval: Mid-Review Decisions ‘Not The Norm’ But Will Continue, FDA’s Cavazzoni says

20 Jul 2022

Without directly referencing the agency’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm, CDER director Patrizia Cavazzoni defended US FDA’s ability to decide on use of the expedited pathway during an application review, while also stressing the need for earlier planning on evidence generation and confirmatory trials.

Exception to the rule — Mid-review decisions to use accelerated approval are the exception to the rule on early interactions regarding surrogates and confirmatory trial planning. • Source: Shutterstock

Without directly referencing Biogen, Inc.’s Alzheimer’s drug Aduhelm (aducanumab-avwa), the leader of the US Food and Drug Administration’s drugs center defended the agency’s ability to make “rare” decisions about the use of accelerated approval during the course of an application review.

Speaking at a 20 July Friends of Cancer Research meeting on use of circulating tumor DNA in the development of cancer therapies, Center for Drug Evaluation and Research director Patrizia Cavazzoni emphasized the importance of early planning and coordination between sponsors and the FDA to develop the evidence needed to support an

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