ROCKVILLE, Md. The Food and Drug Administration has approved the first drug for treating a cancer that occurs in fewer than 10,000 patients in the United States every year.
The agency announced the approval of Allos Therapeutics’ Folotyn (pralatrexate) as a treatment for peripheral T-cell lymphoma, an often aggressive form of non-Hodgkins lymphoma.
Like other lymphomas, PTCL affects the lymphatic system, part of the immune system, particularly T-cells.
“Folotyn’s approval demonstrates FDA’s commitment to the rapid approval of drugs for rare and uncommon diseases,” FDA Center for Drug Evaluation and Research Office of Oncology Drug Products director Richard Pazdur said in a statement.
The FDA said it approved the drug based on evidence that it reduces tumor size. In a late-stage clinical trial of 109 patients using Folotyn, 27% experienced reduction in tumor size. Because of the relative rarity of the disease, the drug received a six-month review rather than the standard 10 months.