The FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.
PML is a rare but serious viral brain infection that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations. Signs and symptoms of PML may develop over the course of several weeks or months and may include changes in mood or usual behavior, confusion, thinking problems, memory loss, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.
Adcetris is used to treat Hodgkin’s lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. One case of PML was described in the Warnings and Precautions section of the Adcetris label at the time of its approval in August 2011.
Patients developing any signs and symptoms of PML should notify their healthcare professionals immediately. Healthcare professionals should withhold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed.
In addition, a new Contraindication was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary toxicity.