Belinostat has an excellent safety profile as one of the drug's
In clinical trials, comprising more than 1050 patients,
belinostat is well-tolerated.
The most frequently reported adverse events are mild and
Belinostat has been administered as monotherapy and combination
therapy for the treatment of cancers. The combination therapies
include idarubicin, doxorubicin, 5-fluorouracil,
carboplatin/paclitaxel, and bortezomib.
Considering the cancers treated and chemotherapies used in
combination therapy studies, the adverse events observed are
Compared to other HDACis, belinostat's preliminary safety data
show lower incidences of the grade 3-4 adverse events (AE) within
the most commonly reported AEs (nausea, fatigue, diarrhea,
In addition, other HDACis have significant side effects with
hematological toxicity in drug combinations while belinostat
seemingly does not.
Serious AEs related to belinostat have been relatively
infrequent and no clusters that suggest a significant risk for the
patients can be identified.
In a safety analysis in patients treated with belinostat as
either mono- and/or combination therapy, the potential benefit of
belinostat treatmentoutweighs the risks for the patients.
Considering the cancers treated, the benefit/risk ratio for
belinostat mono- and combination therapy appears favorable.