FDA Approves Belinostat to Treat Rare Lymphoma

The FDA has approved belinostat for peripheral T-cell lymphoma.

Earlier today the US Food and Drug Administration (FDA) granted accelerated approval to belinostat (Beleodaq) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and aggressive type of non-Hodgkin lymphoma.

“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

The FDA also approved pralatrexate (Folotyn) in 2009 and romidepsin (Istodax) in 2011 for patients with PTCL.

“Today’s approval expands the number of treatment options available to patients with serious and life-threatening diseases,” added Pazdur.

The trial that led to the approval, the BELIEF study, was a multicenter single-arm trial that included 120 patients with refractory or relapsed PTCL (patients had a median of two prior treatments). The median age of patients in the trial was 64 years. The drug was administered intravenously at a dose of 1,000 mg/m² once daily on days 1-5 of a 21-day cycle.

The primary endpoint of the trial was overall response rate. The study found that 25.8% of patients responded to treatment with belinostat, with partial responses occurring in 15% of patients and complete response in 10.8%. The median duration of response was 8.4 months.

Pyrexia, anemia, nausea, vomiting, and fatigue were the most common adverse events in the trial. Sixteen percent of patients experienced thrombocytopenia (grade 3/4 in 7%). Nearly half of patients had serious adverse events (47%). The most common of those (occurring in more than 2% of patients) were pyrexia, infection, anemia, increased creatinine, pneumonia, thrombocytopenia, and multi-organ failure. One belinostat-related death, due to hepatic failure, was reported.