FDA touts new au­thor­i­ty as ODAC hosts ad­comm to re­view de­layed con­fir­ma­to­ry tri­als for ac­cel­er­at­ed ap­provals

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee will meet Thurs­day to look at two can­cer drugs that first won ac­cel­er­at­ed ap­proval in 2009 and 2014 but have failed to com­plete their con­fir­ma­to­ry tri­als.

The two drugs are both in­di­cat­ed for re­lapsed or re­frac­to­ry pe­riph­er­al T cell lym­phoma (PT­CL) and from Acrotech Bio­phar­ma: Folo­tyn (prala­trex­ate) and Beleo­daq (be­li­no­s­tat).

The agency not­ed in brief­ing doc­u­ments re­leased Tues­day ahead of the meet­ing that there have been “sub­stan­tial de­lays” in an up­dat­ed con­fir­ma­to­ry tri­al the spon­sor pro­posed, as well as,

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