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.
The drug is inserted into the bladder after surgery and is activated by enzymes over-expressed by bladder cancer cells.
Spectrum filed notice of the FDA’s rejection in an SEC filing, noting that it may try a new Phase III trial to replace another study that’s already been halted — even though the company’s web site says the recruitment is still underway. The company has claimed that the halted Phase III study was designed with FDA feedback in mind, based on what it had already learned in Phase III.
Based on the discussions, the Company is evaluating a new smaller study that would replace the ongoing Phase 3 program in which enrollment has been stopped.
The company had planned to start selling the drug as Qapzola.
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