New Non-Hodgkin Lymphoma Treatment Approved by the U.S. Food and Drug Administration

Leukemia and Lymphoma Society
Monday, 30 June 2003

The U.S. Food and Drug Administration today approved Bexxar® (tositumomab and iodine I-131 tositumomab) for the treatment of patients with CD20 positive, follicular, non-Hodgkin lymphoma who are resistant to Rituxan® (rituximab) and have relapsed following chemotherapy. Bexxar will be co-marketed in the United States by Corixa Corp. and GlaxoSmithKline and available to physicians in approximately 30 days.

Bexxar is a dual-action radioimmunotherapy that combines the tumor-targeting ability of a cancer-killing monoclonal antibody (tositumomab) with the therapeutic potential of radiation (iodine-131). Together, these agents form a radiolabeled monoclonal antibody that binds to the target antigen CD20 found on non-Hodgkin lymphoma cells. As a result, the therapy initiates an immune response against the cancer and delivers a dose of radiation directly into the cancer cells.

"The FDA-approval of Bexxar is good news for non-Hodgkin lymphoma patients who've failed Rituxan and relapsed from chemotherapy," says Robin Kornhaber, M.S.W., Senior Vice President of Patient Services, The Leukemia & Lymphoma Society. "Now doctors have a new weapon in their treatment arsenal."

Bexxar is administered intravenously in two sets of infusions, seven to 14 days apart, according to the drug's manufacturer. In most cases, patients can receive Bexxar on an outpatient basis. The drug is the only non-Hodgkin lymphoma treatment with dosages tailored to each individual patient.

About Non-Hodgkin Lymphoma

Non-Hodgkin lymphoma is a general term for a group of cancers that originates in the lymphatic system. Lymphoma results when a lymphocyte (a type of white blood cell) undergoes a malignant change and begins to multiply, eventually crowding out healthy cells and creating tumors which enlarge the lymph nodes or other sites in the body. Fifty-eight percent of blood cancers are lymphomas. Rates of non-Hodgkin lymphoma increase with age. Approximately 53,400 Americans were diagnosed with non-Hodgkin lymphoma in 2003, and it is estimated that 314,400 people in the United States are currently living with the disease.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society, headquartered in White Plains, NY, is the world's largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The Society's mission is to cure leukemia, lymphoma, Hodgkin's disease and myeloma, and to improve the quality of life of patients and their families. Since its founding in 1949, the Society has provided more than $358 million for research specifically targeting blood cancers.

For more information, visit www.LLS.org or call the Society's Information Resource Center (IRC), a call center staffed by master-level social workers, nurses and health educators who provide information, support and resources to patients and their families and caregivers. IRC specialists are available at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. Eastern time.

For more information, or to contact Leukemia and Lymphoma Society, see their website at: www.leukemia.org