Richard Pazdur (via AACR)

Break­ing with past com­ments, FDA's Richard Paz­dur telegraphs rough road ahead for Lil­ly's Chi­na-de­vel­oped can­cer drug

The bio­phar­ma in­dus­try has re­cent­ly seen a groundswell of com­pa­nies at­tempt­ing to get their can­cer drugs ap­proved us­ing da­ta from Chi­na, name­ly Eli Lil­ly and EQRx. But Richard Paz­dur, the FDA’s on­col­o­gy chief, threw cold wa­ter on that no­tion Fri­day — de­spite pre­vi­ous com­ments in­di­cat­ing reg­u­la­tors would be open to the idea.

In The Lancet last Fri­day, Paz­dur wrote that there would be sig­nif­i­cant hur­dles in ap­prov­ing a drug based on da­ta from a sin­gle for­eign coun­try. In par­tic­u­lar, he not­ed Lil­ly and In­novent’s Phase III tri­al eval­u­at­ing the an­ti-PD-1 an­ti­body sin­til­imab, slat­ed for an ODAC ad­comm this week, “rais­es ques­tions” about how da­ta from such pop­u­la­tions may prove too ho­mo­ge­neous.

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