The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label. In addition, a new Contraindication warning against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity has been added to the drug label. For more information please visit: Adcetris
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