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BRIEF-Fda staff says results supporting effect of Puma Biotechnology's neratinib

May 22 Fda Staff -

* Based On Sensitivity Analyses Conducted, Results Appear To Be Generally Similar To Primary Analysis Results, Supporting Effect Of Puma Biotechnology Inc's Neratinib

* Tolerability of neratinib in patient population is a concern given frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea

* Results from ongoing phase 2 study 6201 for neratinib suggest that antidiarrheal prophylaxis decreases the incidence and severity of diarrhea Source text (bit.ly/2rtvRyY) Further company coverage:

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