Spectrum Failed To Heed FDA Advice On Apaziquone, And Is Paying The Price
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.
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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 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.
South Korea's Hanmi Pharmaceutical and its global partner Spectrum Pharmaceuticals are moving closer to the commercialization of the oral pan-HER inhibitor poziotinib in the US with the submission by the US biotech of a Phase II breast cancer protocol to the FDA as part of an IND application. But the partners are having to fine-tune their development strategy given what is a crowded sector.