'Reg­u­la­to­ry flex­i­bil­i­ty is not war­rant­ed': FDA balks at al­low­ing Chi­na-on­ly da­ta for Eli Lil­ly's an­ti-PD-1 an­ti­body

Ahead of Thurs­day’s ODAC meet­ing for Eli Lil­ly’s an­ti-PD-1 sin­til­imab, FDA said that the Chi­na-based piv­otal tri­al on which the ap­pli­ca­tion is based “rais­es sig­nif­i­cant ques­tions re­gard­ing da­ta from a sin­gle for­eign coun­try to sup­port a U.S. ap­proval and its gen­er­al­iz­abil­i­ty to a di­verse Amer­i­can pop­u­la­tion,” ac­cord­ing to brief­ing doc­u­ments re­leased Tues­day.

The agency even went so far as to say that Phase III tri­al for the po­ten­tial can­cer drug, known as ORI­ENT-11, does not align with prin­ci­ples de­scribed in ICH guid­ance E17 on plan­ning and de­sign­ing mul­ti-re­gion­al clin­i­cal tri­als, and does not ful­fill the reg­u­la­to­ry statutes out­lined in 21 CFR 314.106, which makes clear that the for­eign da­ta must be ap­plic­a­ble to the US pop­u­la­tion and US med­ical prac­tice.

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