FDA Approves First Radioactive Antibody for Cancer Treatment; Fox Chase Cancer Center Involved in Clinical Trials Leading to Zevalin's Approval
PHILADELPHIA (February 20, 2002) - The U.S. Food and Drug Administration today announced the approval of Zevalin for the treatment of non-Hodgkins lymphoma (NHL). Zevalin (IDEC Pharmaceuticals Corporation) is the first radioimmunotherapy to receive FDA approval for treating cancer. Fox Chase Cancer Center in Philadelphia participated in a series of clinical trials leading to its approval.
"Radioimmunotherapeutic agents are made by linking monoclonal antibodies with radioactive isotopes," explains Russell Schilder, M.D., medical oncologist and the principal investigator of the Zevalin study at Fox Chase Cancer Center. "The antibodies are created in a laboratory and have a very high degree of specificity to recognize and attach to substances on the surface of certain cells."
Antibodies are naturally occurring proteins that the body creates in response to infections. They attach to targets, such as viruses, in a very specific manner and direct the body's defense against the disease. In this case, the antibodies were generated by immunizing mice with human NHL cells and therefore are specific for NHL. The mouse cells that produced these antibodies were isolated and immortalized to provide a source of large quantities of identical, or monoclonal, antibodies to NHL.
Zevalin is more likely to be available at sites that are equipped to develop and administer the radioactive material. At Fox Chase Cancer Center, Zevalin is assembled in the laboratory of Gregory P. Adams, Ph.D., an associate member in the department of medical oncology, by using a strong linking agent to bind the radioactive isotope (yttrium-90) to the mouse monoclonal antibody.
"When injected into a patient with B-cell non-Hodgkin's lymphoma, the monoclonal antibodies carrying radioactive particles circulate in the body until they locate their specific target (antigen) found on the surface of normal and malignant B-cells," explains Adams. "Then, Zevalin attaches itself to the cancer cells and delivers its radioactive payload (yttrium-90) destroying the cancer cells and some normal B-cells. The normal B-cells subsequently are regenerated by the body."
Schilder adds, "NHL is an inherently radiation-sensitive malignancy, making radioimmunotherapy an excellent treatment method for this disease. This cancer regimen is administered on an outpatient basis. Zevalin does not require that patients be quarantined. After treatment, patients are able to return home and resume relatively normal activities."
The primary side effect of Zevalin, is a reduction in blood-cell counts due to myelosuppression (decreased blood-cell production by the bone marrow). However, these toxicities are manageable for most patients treated with Zevalin. In some instances supportive medications or transfusion may be necessary. Blood counts usually are at the lowest about 4-6 weeks after treatment and recover after another two-to-four weeks.
Non-Hodgkin's lymphoma (NHL) is a group of several closely related cancers that affect the body's lymphatic system. Once a rare disease, NHL is now the fifth most common cancer in the United States. It is estimated that approximately 300,000 people are currently living with NHL in the U.S.
Fox Chase Cancer Center, one of the nation's first comprehensive cancer centers designated by the National Cancer Institute in 1974, conducts basic and clinical research; programs of prevention, detection and treatment of cancer; and community outreach. For more information about Fox Chase activities, visit the Center's web site at www.fccc.edu.
Fox Chase Cancer Center, part of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship, and community outreach. For more information, call 1-888-FOX CHASE or (1-888-369-2427).