ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

Af­ter the FDA lam­bast­ed their PD-1 ahead of an ad­comm ear­li­er this week, In­cyte ran in­to new trou­ble Thurs­day as ODAC pan­elists vot­ed against an ac­cel­er­at­ed OK by a wide mar­gin.

Mem­bers of the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee rec­om­mend­ed with a 13-4 vote to de­fer a reg­u­la­to­ry de­ci­sion on In­cyte’s reti­fan­limab un­til af­ter more da­ta can be col­lect­ed from a place­bo-con­trolled tri­al. The PD-1 ther­a­py is due for a PDU­FA date in late Ju­ly af­ter re­ceiv­ing pri­or­i­ty re­view ear­li­er this year.

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