'Well un­der­way': FDA calls for faster con­fir­ma­to­ry tri­als for ac­cel­er­at­ed ap­provals

The FDA’s On­col­o­gy Cen­ter of Ex­cel­lence on Thurs­day out­lined what more the agency can do to speed up con­fir­ma­to­ry tri­als to en­sure drugs ap­proved un­der the ac­cel­er­at­ed path­way are clin­i­cal­ly ben­e­fi­cial.

Be­fore re­view­ing two Acrotech Bio­phar­ma ther­a­pies, FDA of­fi­cials took ques­tions from an ad­vi­so­ry com­mit­tee of can­cer ex­perts on the agency’s wider plans for re­form­ing the ac­cel­er­at­ed ap­proval process. Acrotech mar­kets two drugs: Folo­tyn (prala­trex­ate) and Beleo­daq (be­li­no­s­tat), both of which re­ceived ac­cel­er­at­ed ap­proval, are in­di­cat­ed for re­lapsed or re­frac­to­ry pe­riph­er­al T cell lym­phoma (PT­CL) and have lin­gered for years with­out com­plet­ing con­fir­ma­to­ry tri­als.

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