Spectrum Hopes For Synergies With Allos Acquisition Amid Phase III Setback
This article was originally published in The Pink Sheet Daily
Spectrum issued a tender offer of $1.82 per share for Allos Therapeutics on the same day that it announced the Phase III failure of its bladder cancer drug.
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Under sponsor's current timetable, a single, two-part trial for pralatrexate and belinostat would not complete until 2030, resulting in respective delays of 21 and 16 years in confirming or refuting clinical benefit following accelerated approval. ODAC will discuss Acrotech’s delayed confirmatory trial program on 16 November.
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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