Boxed Warning, New Contraindication Added to Brentuximab’s Label
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)