Spectrum's Apaziquone: Can Two Failed Studies Lead To An Approval?
Spectrum says 6% reduction in bladder cancer recurrence is clinically meaningful even though studies failed their primary endpoint; FDA advisory committee also will weigh issues of data pooling and timing of drug administration.
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FDA's original advice against NDA submission foreshadows advisory committee conclusion that substantial evidence of efficacy in bladder cancer not demonstrated by two negative trials and a post hoc pooled analysis.
Faced with two unsuccessful pivotal trials, FDA advisory committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been demonstrated.
Spectrum Pharmaceuticals has reacquired the rights to apaziquone from Allergan, but the company's stock price likely rose higher on 31 January due to Spectrum's announcement that the US FDA will allow submission of a new drug application (NDA) based on statistically significant results in a pooled data analysis from two failed Phase III bladder cancer studies.