On July 3, the Food and Drug Administration (FDA) granted accelerated approval to Beleodaq (belinostat) for treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the third drug that has been approved since 2009 for treating patients with this rare form of lymphoma. Folotyn (pralatrexate) and Istodax (romidepsin) were approved for use in this same patient population in 2009 and 2011, respectively.
PTCL is a fast-growing immune system cancer affecting the T cells.More than 70,000 Americans are expected to receive a diagnosis of non-Hodgkin lymphoma this year, and 10 to 15 percent of those cases will be PTCL, according to the National Cancer Institute.
The FDA based its decision on a single arm clinical trial of 120 participants who had received at least one prior treatment. Participants received the experimental drug until they experienced disease progression or an unacceptable toxicity. The overall response rate (meaning the percentage of participants who experienced either a complete or partial response to the treatment) was 25.8 percent, with a median response duration time of 8.4 months.
Side effects included nausea, fatigue, fever, low red blood cells and vomiting. A small number of participants (less than 2 percent) experienced serious side effects, including pneumonia, infection, thrombocytopenia and organ failure. To receive full approval from the FDA, the manufacturer must continue to evaluate Beleodaq's effectiveness in further clinical trials.
Beleodaq is also being studied in other cancer types, including liver, ovarian and non-small cell lung.
