Spectrum Pharma Plays With a New Phase III Concept After the FDA Formally Spurns 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.