Pralatrexate (Folotyn, Allos) has been approved as the first agent to treat peripheral T-cell lymphoma (PTCL), often an aggressive type of non-Hodgkin’s lymphoma. Pralatrexate was designated as an orphan drug under the agency’s accelerated approval process.
The approval was based on evidence that it reduced tumor size, as shown on imaging scans in one study.
Adverse reactions included irritation or sores of the oral and digestive mucous membranes; low platelet cell and white blood cell counts; fever; nausea; and fatigue. Patients who take pralatrexate should take folate and vitamin B12 supplements to reduce mucous membrane irritation.
For more information, please see this month’s Pharmaceutical Approval Update on page 636.
Source: FDA, September 25, 2009