FDA un­sur­pris­ing­ly brings down the ham­mer on In­cyte's PD-1 — draw­ing a line for fu­ture ac­cel­er­at­ed ap­provals

It ap­pears the PD-(L)1 hon­ey­moon is fi­nal­ly over.

In­cyte $IN­CY re­vealed late Fri­day the FDA has slammed its PD-1 reti­fan­limab — which was un­der pri­or­i­ty re­view for lo­cal­ly ad­vanced or metasta­t­ic squa­mous cell car­ci­no­ma of the anal canal — with a com­plete re­sponse let­ter, de­mand­ing “ad­di­tion­al da­ta” to show clin­i­cal ben­e­fit.

On one hand, the re­jec­tion should come as no sur­prise: Reg­u­la­tors spelled out the prob­lems they saw with In­cyte’s da­ta pack­age in no un­cer­tain terms, rais­ing con­cerns about the low re­sponse rates, lack of di­ver­si­ty and dearth of safe­ty da­ta in the sin­gle-arm tri­al. Dur­ing the en­su­ing ad­comm, the FDA’s can­cer czar, Richard Paz­dur, sug­gest­ed the whole episode un­der­scores the need to “re­assess” how drugs get ap­proved un­der the ac­cel­er­at­ed ap­proval path­way with­out ran­dom­ized stud­ies.

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