The US Food and Drug Administration (FDA) has issued a warning about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).
This warning comes after two new cases of progressive multifocal leukoencephalopathy a rare but serious brain infection.
A new Boxed Warning highlighting this risk has been added to the drug label.
In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of lung toxicity.
Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma.
Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.
Source: FDA site
