New Warnings Added for Lymphoma Drug ► NCI Cancer Bulletin for January 24, 2012 - National Cancer Institute

NCI Cancer Bulletin for January 24, 2012 - National Cancer Institute

New Warnings Added for Lymphoma Drug

The Food and Drug Administration (FDA) has added a boxed warning for the lymphoma drug brentuximab vedotin (Adcetris) highlighting the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious viral infection of the brain that can result in death. The agency has also added a new contraindication warning against the use of brentuximab vedotin with the cancer drug bleomycin due to increased risk of lung toxicity, characterized by cough or shortness of breath.

The FDA approved brentuximab vedotin for patients with Hodgkin lymphoma and systemic anaplastic large cell lymphoma in August 2011. The treatment combines a drug with an antibody that directs the drug to a target on lymphoma cells. At the time of the drug’s approval, one case of PML was described in the drug’s safety information. In a drug safety communication issued January 13, the FDA alerted the public to two additional cases of PML.

The signs and symptoms of PML can develop over several weeks or months. They may include changes in mood or in usual behavior; confusion; thinking problems; loss of memory; changes in vision, speech, or walking; and decreased strength or weakness on one side of the body. Patients who develop any signs or symptoms of PML should notify their health care professional immediately. Brentuximab vedotin treatment should be suspended if PML is suspected and discontinued if PML is confirmed.

Patients and health care professionals should report serious side effects from the use of brentuximab vedotin, including confirmed cases of PML, to the FDA MedWatch program online or by calling 1-800-332-1088.