Safety profile

Belinostat has an excellent safety profile as one of the drug's key characteristics.

In clinical trials, comprising more than 1050 patients, belinostat is well-tolerated.

The most frequently reported adverse events are mild and manageble.

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 acceptable.

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, vomiting).

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.