It's the first new drug approved to treat Hodgkin's lymphoma in nearly 35 years and the first lymphoma drug specifically indicated for ALCL.
"Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response" to the drug, says Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, in a news release.
Lymphomas are cancers of the lymphatic system, a network of lymph nodes connected by vessels that transport lymph fluid. Symptoms of lymphoma include swollen lymph nodes, fever, weight loss, and fatigue.
The two main types of lymphomas are Hodgkin's lymphoma and non-Hodgkin's lymphomas.
The National Cancer Institute estimates that nearly 9,000 new cases of Hodgkin's lymphoma will be diagnosed in 2011 and about 1,300 people will die from the disease.
Systemic ALCL is a rare type of non-Hodgkin's lymphoma that can appear in several parts of the body including the lymph nodes, skin, bones, and soft tissues.
How Adcetris Works
Adcetris (brentuximab vedotin) combines an antibody and drug that allows the antibody to direct the drug to a target on lymphoma cells known as CD30.
The drug is designed to be used in people with Hodgkin's lymphoma whose disease has progressed after treatment with bone marrow stem cell transplant or those who have had two chemotherapy treatments and are not eligible for transplant.
In people with ALCL, the drug is approved for treatment in people whose disease has progressed after one prior chemotherapy treatment.
The FDA based its approval on a study of 102 people with Hodgkin's lymphoma. Seventy-three percent of those treated with Adcetris experienced either a complete or partial cancer shrinkage response to the drug for an average of about six months.
In people with ALCL, the drug was evaluated in a study involving 58 people. Eighty-six percent of those who took Adcetris had a full or partial response to the drug for an average of more than 12 months.
The most common side effects associated with Adcetris were a decrease in disease-fighting white blood cells, nerve damage, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels.
The FDA says pregnant women should be aware that Adcetris might cause harm to their unborn child.
Adcetris is marketed by Seattle Genetics of Bothell, Wash.