In­cyte yanks EU ap­pli­ca­tion for PD-1 drug, cit­ing in­abil­i­ty to an­swer reg­u­la­tors' 'ma­jor con­cern­s'

Hop­ing to wedge its way in­to a crowd­ed PD-(L)1 field, In­cyte faced a huge set­back when the FDA sent back its ap­pli­ca­tion for an ini­tial in­di­ca­tion ear­li­er this year. Now, the drug­mak­er is giv­ing up hope in Eu­rope as well.

In­cyte has with­drawn its EU ap­pli­ca­tion for PD-1 drug Zynyz, or reti­fan­limab, af­ter say­ing it couldn’t ad­e­quate­ly ad­dress the CHMP’s ques­tions over sur­vival da­ta un­der­pin­ning its mar­ket hopes in squa­mous cell car­ci­no­ma of the anal cav­i­ty, the EMA re­vealed.

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