FDA announced accelerated approval of pralatrexate, the first drug approved for peripheral T-cell lymphoma. The approval comes just weeks after the FDA’s Oncologic Drug Advisory Committee voted 10-4 in favor of the drug’s accelerated approval for the treatment of this rare form of non-Hodgkin’s lymphoma.

“Folotyn’s approval demonstrates FDA’s commitment to the rapid approval of drugs for rare and uncommon diseases,” Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The drug, which is manufactured by Allos Therapeutics Inc., was approved based on its ability to reduce tumor size. A study of 109 patients with peripheral T-cell lymphoma demonstrated that 27% of patients experienced reduced tumor size, as seen on imaging scans.

Pralatrexate was granted priority review to speed its availability and was designated an orphan drug to provide various financial incentives to manufacturers who develop drugs for a small number of patients with rare disorders.

According to the FDA press release, irritation or sores of the mucous membranes, such as the lips, mouth and digestive tract; low platelet cell counts; low white blood cell counts; fever; nausea and fatigue were the most common adverse reactions. In addition, pralatrexate poses danger to fetuses; women should avoid becoming pregnant while being treated with the drug and pregnant women should be informed of potential risks.

To reduce mucous membrane irritation, pralatrexate should be taken with folate and vitamin B12 supplements.

Respective :

Pralatrexate is clearly active in peripheral T-cell lymphoma but by no means is it a homerun for this disease. Nevertheless, it is nice to add another quill in our armamentarium for the treatment of peripheral T-cell lymphoma, which has been notoriously difficult to treat with our current medications. I foresee the day when pralatrexate will be one among multiple new drugs combined to treat T-cell lymphoma very much like the way we use CHOP today.

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