FDA serves up a quick re­jec­tion of Chi­na-on­ly da­ta with a CRL for Lil­ly's PD-1

The FDA sent over a quick re­jec­tion let­ter on Thurs­day to Eli Lil­ly re­gard­ing its an­ti-PD-1 an­ti­body sin­til­imab, fur­ther crush­ing the hopes of any com­pa­nies look­ing to bring cheap­er fol­low-ons based on­ly on Chi­nese da­ta.

The com­plete re­sponse let­ter (CRL) fol­lows a near­ly unan­i­mous On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee (ODAC) rec­om­men­da­tion against sin­til­imab’s ap­proval, which was in­tend­ed as a first-line treat­ment for peo­ple with non­squa­mous non-small cell lung can­cer. The FDA al­so re­vealed at the meet­ing that the com­pa­ny sub­mit­ted the ap­pli­ca­tion with­out con­sult­ing reg­u­la­tors be­fore the tri­al con­clud­ed, and mis­rep­re­sent­ed in­ter­ac­tions with the agency dur­ing its pre­sen­ta­tion.

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