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FDA: Rare Brain Infection Prompts Boxed Warning for Brentuximab
FDA: Rare Brain Infection Prompts Boxed Warning for Brentuximab
D Mahoney
20120013
2012 Jan 13
Elsevier Global Medical News
FDA: Rare Brain Infection Prompts Boxed Warning for Brentuximab
Elsevier Global Medical News. 2012 Jan 13, D Mahoney
The Food and Drug Administration on Jan. 13 announced that a boxed warning will be added to the label of brentuximab vedotin because of reports of two cases of progressive multifocal leukoencephalopathy associated with the drug's use in lymphoma patients.Brentuximab vedotin (Adcetris) was approved in August 2011 for the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. At the time of its approval, the warnings and precautions label described one case of progressive multifocal...