FRIDAY, Sept. 25, 2009 (HealthDay News) -- The drug Folotyn (pralatrexate) has been approved to treat Peripheral T-cell Lymphoma (PTCL), an often aggressive form of non-Hodgkin's lymphoma, the U.S. Food and Drug Administration said Friday.
The drug, given accelerated approval because it treats an unmet medical need, was sanctioned for people whose disease has returned or hasn't responded to other types of chemotherapy, the agency said in a news release.
PTCL strikes fewer than 9,500 people each year in the United States, the FDA said. The disease affects a type of white blood cell, called a T-cell, involved in the body's disease-fighting immune system.
Approval of Folotyn was based on clinical data showing it reduced tumor size in 27 percent of 109 people with PTCL who were studied. The most common adverse reactions included sores of the lips, mouth and digestive tract, low white blood cell counts, fever, nausea and fatigue.
Since the drug can harm a fetus, women taking Folotyn should avoid becoming pregnant, the FDA said. Anyone taking the drug should also take folate and vitamin B12 supplements to help reduce irritation of the mucous membranes.
Folotyn is produced by Colorado-based Allos Therapeutics, which is required to conduct additional studies of tumor shrinkage and life expectancy, the agency said.
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