BETHESDA, MD 03 Jul 2014—FDA today announced it approved the marketing of belinostat, or Beleodaq, for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).
Richard Pazdur, head of FDA's Office of Hematology and Oncology Products, said the drug is the third one that the agency has approved since 2009 for the treatment of PTCL.
The labeling (PDF) for belinostat, a histone deacetylase inhibitor, recommends a dosage of 1000 mg per square meter of body surface area once daily on days 1–5 of a 21-day treatment cycle. In patients homozygous for the UGT1A1*28 allele, a variant of the uridine glucuronosyltransferase 1A1 gene, the starting dose should be 750 mg per square meter. Doses should be given by i.v. infusion over 30 minutes. This infusion time may be extended to 45 minutes if infusion-site pain or other symptoms attributable to the infusion occur.
Thrombocytopenia or neutropenia during a treatment cycle may necessitate a 25% decrease in each dose during the next cycle, depending on the patient's platelet or absolute neutrophil count. If nausea, vomiting, and diarrhea occur for more than seven days despite supportive management, the labeling recommends decreasing each dose in the next treatment cycle by 25%. Two such reductions necessitate discontinuation of belinostat therapy.
Treatment cycles can be repeated until the disease progresses or unacceptable toxicity occurs, the labeling states.
During the open-label, single-group, nonrandomized international trial of belinostat in 129 patients with relapsed or refractory PTCL, the most common adverse reactions were nausea, fatigue, fever, anemia, and vomiting. The labeling reports that each of these reactions occurred in at least 29% of the patients.
In 26% of the patients in the trial, their PTCL shrank or disappeared, the labeling reports. This response typically started to occur in the first six weeks of treatment.
Beleodaq will be available in single-use vials containing 500 mg of lyophilized belinostat. The vials should be stored at 20–25 °C
To reconstitute the drug in a vial, the labeling says to add 9 mL of sterile water for injection and then swirl the contents. This 50-mg/mL solution may be stored for up to 12 hours at 15–25 °C.
To prepare an infusion of belinostat for administration, the labeling says to transfer the required dose to a bag containing 250 mL of 0.9% sodium chloride injection. This infusion bag may be stored for up to 36 hours, which includes the 30 or 45 minutes for drug administration, at 15–25 °C. The infusion set should have a 0.22-µm inline filter.
The labeling states that belinostat is a cytotoxic drug and requires proper handling and disposal. Belinostat is also genotoxic; women should avoid pregnancy while receiving the drug.
Beleodaq will be marketed by Spectrum Pharmaceuticals Inc.
Topotarget, the Denmark-headquartered company that developed belinostat and licensed the North American rights to Spectrum, said the new product will be available to patients this month.