Spec­trum floats new PhI­II idea af­ter FDA slaps down failed blad­der can­cer drug

Af­ter field­ing two failed Phase III stud­ies and watch­ing an FDA com­mit­tee vote unan­i­mous­ly against an ap­proval, you might say that to­day’s for­mal re­jec­tion of Spec­trum Phar­ma­ceu­ti­cals’ blad­der can­cer treat­ment apaz­iquone was some­thing of a fore­gone con­clu­sion. And Spec­trum $SP­PI says it’s al­ready con­sid­er­ing start­ing a new Phase III in yet an­oth­er at­tempt to win an ap­proval.

Spec­trum’s R&D team came up with a post hoc pooled analy­sis to find the pos­i­tive da­ta it want­ed to see in their two late-stage stud­ies. But nei­ther of the two tri­als were able to pro­vide sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments pre­vent­ing dis­ease re­cur­rence.

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