The US Food and Drug Administration (FDA) has approved Folotyn (pralatrexate), the first treatment for peripheral T-cell lymphoma (PTCL), an aggressive form of non-Hodgkins lymphoma.
Folotyn, produced by Allos Therapeutics, received approval under the FDA’s accelerated approval process, which speeds up approval for new drugs to treat rare and uncured diseases.
In this case, the FDA based the approval of Folotyn on clinical studies, which showed a reduction in tumour size in 27% of 109 patients participating in the trial.
Tumour shrinkage is accepted by the FDA as reasonable grounds that a drug has significant clinical benefits. As a condition of accelerated approval, however, Allos will still need to conduct studies to confirm that tumour shrinkage will extend patient life.
The FDA’s Center for Drug Evaluation and Research director of the Office of Oncology Drug Products Richard Pazdur said that Folotyn’s approval demonstrates the FDA’s commitment to the rapid approval of drugs for rare and uncommon diseases.
The drug was also designated as an orphan drug, which provides a variety of financial incentives for manufacturers.
The most common adverse reactions seen with Folotyn were irritation or sores of the mucous membranes such as the lips, the mouth and the digestive tract, low platelet cell counts, low white blood cell counts, fever, nausea and fatigue.