FDA hits Hutchmed, Jun­shi drugs with CRLs — fur­ther clar­i­fy­ing its stance on Chi­na-on­ly da­ta

The FDA is firm­ly shut­ting the door to Chi­na-on­ly da­ta when it comes to ap­prov­ing new can­cer drugs — with some ex­cep­tions.

Just over a month af­ter hit­ting Eli Lil­ly and In­novent’s sin­til­imab with a com­plete re­sponse let­ter, the agency sent back Hutchmed’s NDA for su­r­u­fa­tinib, a ki­nase in­hibitor that blocks VEG­FR and FGFR, as a treat­ment of pan­cre­at­ic and ex­tra-pan­cre­at­ic neu­roen­docrine tu­mors, cit­ing sim­i­lar con­cerns about da­ta that most­ly came from Chi­na.

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