Brentuximab vedotin
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Progressive multifocal leukoencephalopathy: 3 case reports Two men and one woman developed progressive multifocal leukoencephalopathy (PML) after treatment with brentuximab vedotin [Adcetris; dosages not stated].* One patient later died. A 48-year-old man received brentuximab vedotin for Hodgkin’s lymphoma. After his third dose, he developed slurred speech and left side weakness. CSF investigations revealed JC virus. He worsened rapidly, and died within 4 weeks of symptom onset [treatment not stated]. A 50-year-old man with Hodgkin’s lymphoma presented after his eighth cycle of brentuximab vedotin. His symptoms included speech changes, difficulty writing, right leg weakness, coordination and balance difficulties, and sensory deficits on his left side. A spinal cord lesion biopsy stained positive for JC virus. At last follow-up, his PML had progressed; he lacked motor function and deep tendon reflexes of his legs, and had hand tremor and hypoactive arm reflexes [treatment not stated]. A 38-year-old woman with stage IV cutaneous anaplastic large cell lymphoma received brentuximab vedotin. After her second dose, she presented with trouble reading and finding words to express herself, mild balance problems, and memory lapses. MRI showed demyelination, and biopsy of her brain revealed JC virus. Brentuximab vedotin was withdrawn [outcome not stated]. Author comment: "The U.S. Food and Drug Administration (FDA) 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). . . At the time of Adcetris’ approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label." * See also this issue p5; 803066179 FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin). Internet Document : 17 Jan 2012. Available from: 803066151 URL: http://www.fda.gov/drugs/drugsafety/ucm287668.htm - USA
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Editorial comment: A search of AdisBase, Medline, Embase and the WHO ADR database did not reveal any other case reports of progressive multifocal leukoencephalopathy associated with brentuximab vedotin.
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Reactions 21 Jan 2012 No. 1385
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