Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way sev­er­al times to flat­ten any ex­pec­ta­tions for Spec­trum’s lung can­cer drug pozi­o­tinib, in­clud­ing slam­ming the reg­u­la­to­ry door in the biotech’s face four years ago when the their ex­ec­u­tive crew came call­ing for a break­through drug des­ig­na­tion and en­cour­age­ment from the on­col­o­gy wing of the FDA.

That sting­ing ear­ly re­buke point­ed straight down the path to a cor­ro­sive in-house agency re­view of Spec­trum’s at­tempt to land an ac­cel­er­at­ed ap­proval for the oral EGFR TKI and a pub­lic whip­ping that in­clud­ed a clas­sic take­down by none oth­er than Richard Paz­dur, who slammed the com­pa­ny for “poor drug de­vel­op­ment” that led to con­fu­sion over the dose need­ed for a slice of NSCLC pa­tients har­bor­ing HER2 ex­on 20 in­ser­tion mu­ta­tions.

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