Tuesday, January 24, 2012

FDA Issues Warning About Lymphoma Drug Brentuximab

TheFDA has issued a warning to healthcare professionals about the lymphoma drug brentuximab. 
Two new cases of progressive multifocal leukoencephalopathy (PML), which is a rare but serious brain infection, have been reported. Because of the seriousness of PML, which can result in death, a new boxed warning highlighting this risk has been added to the drug label, according to the FDA.
In addition, a contraindication was added, warning against the use of brentuximab with the cancer drug bleomycin because of the increased risk for pulmonary toxicity.
Brentuximab was in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of approval, 1 case of PML was described in the warnings and precautions section of the label. So there are now 3 cases associated with the drug.
The signs and symptoms of PML can develop over the course of several weeks or months. They can include changes in mood or usual behavior; confusion; thinking problems; loss of memory; changes in vision, speech, or walking; and decreased strength or weakness on one side of the body, the FDA says.
Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.
Brentuximab generated much excitement among experts when study results were presented at the American Society of Hematology annual meeting in 2010. Some of the responses seen in refractory lymphoma were described as "amazing." The new drug is the first to be approved by the FDA for Hodgkin's lymphoma in more than 30 years, the company said.