Brentuximab gets boxed warning

A boxed warning has been added to lymphoma drug brentuximab vedotin (Adcetris) regarding its association with progressive multifocal leukoencephalopathy (PML).

At the time of the drug's approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label. Since then, two additional cases have been reported. Due to the serious nature of PML, the boxed warning was added, according to an FDA statement. Clinicians should hold the drug if PML is suspected and discontinue it if a diagnosis of PML is confirmed.

In addition, a new contraindication was added against use of the drug in combination with bleomycin due to increased risk of pulmonary toxicity.