FDA ad­vi­sors rec­om­mend against ap­prov­ing Eli Lil­ly’s PD-1, cast­ing shad­ow over fu­ture of Chi­na-made can­cer drugs

In a live­ly and some­times con­tentious hear­ing, the FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee (ODAC) near­ly unan­i­mous­ly rec­om­mend­ed against ap­prov­ing Eli Lil­ly and In­novent’s an­ti-PD-1 an­ti­body sin­til­imab, deal­ing a blow to “me-too” can­cer drug­mak­ers hop­ing to reach the mar­ket based sole­ly on da­ta from Chi­na.

But the pan­el’s con­cerns were large­ly over­shad­owed by FDA of­fi­cials tear­ing in­to Lil­ly over not mak­ing good on its promis­es to in­crease tri­al di­ver­si­ty, sub­mit­ting the ap­pli­ca­tion with­out con­sult­ing reg­u­la­tors be­fore the tri­al con­clud­ed and mis­rep­re­sent­ing in­ter­ac­tions with the agency dur­ing its pre­sen­ta­tion.

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