FDA Approves Pralatrexate for Relapsed/Refractory T-Cell Lymphoma

Yael Waknine

September 26, 2009

September 26, 2009 — The US Food and Drug Administration (FDA) has granted accelerated approval and orphan drug status for pralatrexate injection (Folotyn, Allos Therapeutics, Inc) as a single agent for the treatment of relapsed or refractory peripheral T-cell lymphoma. The relatively rare and often aggressive type of non-Hodgkin's lymphoma occurs in fewer than 9500 US patients annually.

"Aggressive peripheral T-cell lymphomas have been a largely ignored group of diseases," said James O. Armitage, MD, Joe Shapiro Professor of Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, in a company news release. "It is exciting to have the first FDA-approved therapy for relapsed or refractory peripheral T-cell lymphoma."

The FDA's action was based on a priority review of data from an open-label, single-group, multicenter, international clinical trial (PROPEL; n = 115), in which patients with relapsed or refractory peripheral T-cell lymphoma received pralatrexate at 30 mg/m2 once weekly by intravenous push during 3 to 5 minutes for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity.

Patients also received 1 mg of vitamin B12 intramuscularly every 8 to 10 weeks and 1 to 1.25 mg of folic acid orally on a daily basis to reduce treatment-related hematologic toxicity and mucositis.

Results showed that 29 (27%) of 109 evaluable patients demonstrated a reduction in tumor size, with the majority of responders (66%) achieving this effect within the first cycle of therapy.

According to the FDA, tumor shrinkage is considered reasonably likely to predict a clinical benefit such as extended survival in cancer patients. Additional studies of pralatrexate are being required to further verify and describe these advantages.

Adverse events most commonly reported in the study included mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%); severe (grade 3/4) adverse events were thrombocytopenia (33%), mucositis (21%), neutropenia (20%), and anemia (20%).

Because pralatrexate can cause fetal harm, women should avoid becoming pregnant during therapy, and pregnant women should be advised of the potential risks to the fetus.

Caution and careful monitoring is advised when treating patients with moderate to severe renal impairment. Coadministration of drugs subject to renal clearance (eg, probenecid, nonsteroidal anti-inflammatory drugs, and trimethoprim/sulfamethoxazole) may result in delayed elimination.

Pralatrexate dosing should be omitted or modified for patients who develop grade 2 or greater mucositis or severe (grade ≥ 3) liver function test abnormalities.

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