Boxed Warning, New Contraindication Added to Brentuximab’s Label

February 2012, Vol 3, No 1 - FDA Approvals, News & Updates


The FDA has issued a boxed warning for brentuximab vedotin (Adcetris, Seattle Genetics) related to the risk of John Cunningham virus infec­tion, leading to progressive multifocal leu­ko­­encephalopathy (PML) and death in patients who take brentuximab to treat Hodgkin lymphoma or systemic anaplastic large-cell lymphoma.

This warning is in response to 2 cases of PML that occurred since the drug’s expedited approval in August 2011. At that time, 1 fatal case had already been noted in the label. The FDA has also added a new contraindication against the concomitant use of brentuximab with the cancer drug bleomycin, because of an increased risk for pulmonary toxicity. (January 13, 2012)