Spectrum's bladder cancer candidate turned down by FDA
US biotech firm Spectrum Pharmaceuticals (Nasdaq: SPPI) has revealed in a filing with the Security and Exchange Commission that it has received a Complete Response Letter from the US Food and Drug Administration relating its investigational bladder cancer treatment.
The CRL is related to the company’s New Drug Application for Qapzola A (apaziquone for intravesical instillation), that is being developed to treat non-muscle invasive bladder cancer (ie, early bladder cancer), which accounts for about 80% of all bladder cancers
On November 15, 2016, Spectrum met with the FDA to discuss the strategy for further development of Qapzola. Based on the discussions, the company is evaluating a new smaller study that would replace the ongoing Phase III program in which enrollment has been stopped.
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