Accelerated approval will be ‘the norm’ for gene therapies, FDA’s Peter Marks says

The FDA will in­creas­ing­ly use ac­cel­er­at­ed ap­proval for gene ther­a­pies aimed at rare con­di­tions, ac­cord­ing to Pe­ter Marks, the FDA’s top of­fi­cial over­see­ing cell and gene ther­a­pies, the clear­est sig­nal yet of how wide­ly the agency will de­ploy its ex­pe­dit­ed path­way.

Marks’ com­ments, made last week at a work­shop in Wash­ing­ton, build on a stance he took last year back­ing ac­cel­er­at­ed ap­proval for gene ther­a­pies, which of­ten tar­get young chil­dren with ul­tra-rare con­di­tions.

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