Adcetris brentuximab vedotin regulatory update

FDA and Seattle Genetics said the label of cancer drug Adcetris brentuximab was updated to include a new boxed warning about the risk of JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death. FDA said it received reports of 2 additional cases of PML in patients receiving the drug. The label also contains a new contraindication warning against use of Adcetris with cancer drug bleomycin due to increased risk of pulmonary toxicity. Last August, FDA granted accelerated approval to Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). At the time, the label's warnings and precautions section described 2 fatal case of PML associated with Adcetris (see BioCentury, Aug. 22, 2011 & Dec. 5, 2011). ...