FDA Approves Adcetris for Two Types of Lymphoma
Article date: August 23, 2011
By Stacy Simon
The Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for treating patients with Hodgkin lymphoma (also known as Hodgkin disease) who have already had a stem cell transplant or are not eligible for one. The drug was also approved for patients with systemic anaplastic large-cell lymphoma (ALCL), who have not improved with at least one previous therapy. This is the first drug approved specifically for ALCL and it’s the first time in 30 years the FDA has approved a new treatment for Hodgkin lymphoma.
Adcetris is a newer type of drug known as an antibody-drug conjugate: a manmade antibody that targets a molecule found on some lymphoma cells, combined with a chemotherapy drug. The antibody acts as a sort of homing signal to bring the chemo drug directly to the lymphoma cells.
The drug’s approval for Hodgkin lymphoma was based on a clinical trial of 102 patients who took Adcetris. Seventy-three percent experienced complete or partial cancer shrinkage after treatment.
Approval for ALCL was based on a study of 58 patients who took Adcetris. Eighty-six percent showed at least some improvement.
Possible side effects of the drug include a decrease in infection-fighting white blood cells (neutropenia), nerve damage (peripheral sensory neuropathy), fatigue, nausea, anemia, upper respiratory infections, diarrhea, fever, cough, vomiting and low blood platelet levels (thrombocytopenia). The drug may cause birth defects if taken by pregnant women.
Adcetris was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.
The drug is marketed by Seattle Genetics.
Reviewed by: Members of the ACS Medical Content Staff
ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.
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