The U.S. Food and Drug Administration on Friday placed its stamp of approval on the drug Adcetris (brentuximab vedotin) for treating Hodgkin lymphoma and a rare lymphoma called systemic anaplastic large cell lymphoma.
Lymphomas are cancers of the lymphatic system. And Adcetris, an antibody-drug, allows the antibody to direct the drug target a type of lymphoma cell known as CD30, the agency said in news release.
Systemic anaplastic large cell lymphoma is a rare malignant tumor (non-Hodgkin lymphoma) that may form in several parts of the body to include the lymph nodes, skin, bones, soft tissue, lungs or liver, according to the National Cancer Institute, or NCI.
Adcetris is the first treatment for fighting Hodgkin lymphoma approved by the FDA since 1977, and the first specifically made to treat anaplastic large cell lymphoma. The drug is marketed by Seattle Genetics of Bothell, Wash.
Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy, said Dr. Richard Pazdur, director of the Office of Oncology Drug Products, in a statement.
The Office of Oncology Drug Products is in the FDA's Center for Drug Evaluation and Research.
A single clinical trial involving 102 patients was used to evaluate the effectiveness of Adcetris in patients with Hodgkin lymphoma. Patients were only treated with that drug. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months, FDA said.
As for the drug's effectiveness in patients with systemic anaplastic large cell lymphoma, it was also determine through a single clinical trial, but involving 58 patients. These patients were also only treated with Adcetris. Eight-six percent experienced either a complete or partial response and responded on average for 12.6 months, according to the FDA.
The most common side effects experienced with Adcetris were a decrease in infection-fighting white blood cells, nerve damage, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels.
NCI estimates that 8,830 new cases of Hodgkin lymphoma will be diagnosed in the United States in 2011 and about 1,300 people will die from the disease.