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Likelihood of FDA approval for belinostat, a histone deacetylase (HDAC) inhibitor, is "fifty-fifty," CEO Dr Rajesh Shrotriya told this news service at the 2012 American Society of Hematology Annual Meeting and Exposition.
Belinostat has a superior side-effect profile compared to other HDAC inhibitors available, Shrotriya said. Zolinza is very toxic, and Istodax causes significant bone marrow suppression among other side effects, he noted. Belinostat in comparison is the safest HDAC inhibitor, he added. Dr Enrique Ocio, hematologist, Hospital Universitario de Salamanca, Spain, countered that belinostat is no exception to the tolerability issues faced by HDAC inhibitors. Toxicity can be limited by lowering its dose, but in general the pivotal trial will have to show a robust toxicity profile for it to be approved, he noted.