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FDA Approval for Belinostat

Brand Name: BELEODAQ™

  • Approved for relapsed or refractory peripheral T-cell lymphoma

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions, and contraindications.

Approved for relapsed or refractory peripheral T-cell lymphoma

On July 3, 2014, the Food and Drug Administration (FDA) granted accelerated approval to belinostat (BELEODAQ™, Spectrum Pharmaceuticals, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The approval was based on the results of a multicenter single-arm trial of 120 evaluable patients with PTCL that had not responded to, or had relapsed after, prior treatment. The trial included patients with baseline platelets less than 100,000/μL. Patients evaluated for efficacy were a median of 64 years old (range 29-81), and 52 percent were male. They had undergone a median of two prior treatments (range 1-8). Belinostat was administered by intravenous infusion at a dose of 1,000 mg/m2 once daily on days 1-5 of a 21-day cycle.

The primary trial endpoint was overall response rate (ORR), as assessed by an independent review committee. The ORR was 25.8 percent (95 percent CI: 18.3, 34.6). The complete response and partial response rates were 10.8 percent and 15.0 percent, respectively. The median response duration (time from first date of response to disease progression or death) was 8.4 months (95 percent CI: 4.5-29.4).

The most common adverse reactions (more than 25 percent) in the safety population (129 patients) were nausea, fatigue, fever, anemia, and vomiting. Thrombocytopenia was reported in 16 percent of patients, with grade 3 or 4 thrombocytopenia in 7 percent of patients. Serious adverse reactions were reported in 47 percent of patients. The most common serious adverse reactions (seen in more than 2 percent of patients) were pneumonia, fever, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure. One treatment-related death due to liver failure was reported.

As a condition of this accelerated approval, FDA requires the sponsor to conduct a dose-finding trial of belinostat combined with CHOP (cyclophosphamide, vincristine, doxorubicin, and prednisone) and a subsequent phase III trial to characterize the comparative efficacy and safety of belinostat in combination with CHOP versus CHOP alone. 

The recommended dose and schedule for belinostat is 1,000 mg/m2 administered over 30 minutes by intravenous infusion once daily on days 1-5 every 3 weeks. 

  • Updated: July 8, 2014