The U. S. Food and Drug Administration (FDA) advisers said that the response rate and duration of response from Allos Therapeutics Inc.'s single-arm study were reasonably likely to predict the clinical benefit of Folotyn (pralatrexate) in treating patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

A spokeswoman of the FDA said that the agency's oncologists voted 10-4 that the company's drug would likely be a boon to T-cell lymphoma patients.

This cancer affects the immune system. Currently there are no other FDA approved drugs for this treatment and Westminister, Colo. Based Allos has requested the FDA to approve its drug for patients whose cancer reoccurs or has not responded to other medication.

Studies conducted by the company showed that 27 percent of patients with T-cell lymphoma responded to treatment with more than half responding for three months.

The FDA panel is scheduled to make a decision on the drug by the 24th Of September.

Paul L. Berns, CEO at Allos Therapeutics said, "We are very pleased that the advisory committee today voted to recommend accelerated approval of the Folotyn NDA".