|
|
| Site Navigation | Monoclonal Antibody Therapy: Bexxar® |
|
Recommended Books:
|
| Bexxar®
(tositumomab and iodine I 131 ), produced
by Corixa Corp., is a radiolabled monoclonal antibody
for the treatment of patients with CD20 positive,
follicular, non-Hodgkin’s
lymphoma (NHL), with and without transformation, whose disease is resistant
to Rituximab and has relapsed following chemotherapy.
It received US Food and Drug Administration approval in mid-2003. How it works Bexxar is an antibody with radioactive iodine 131 attached. The drug attaches to a protein found only on the surface of B lymphocytes such as cancerous B-cells found in many forms of Non-Hodgkin's lymphoma. The radioactivity targets the B-cell, destroying it. Effectiveness The
effectiveness of the BEXXAR regimen was examined in a multi-center,
single-arm study of 40 patients with follicular
NHL whose disease had relapsed following or had not responded to Rituximab.
The median age of patients in the study was 57 (range: 35-78) and
the median number of prior chemotherapies was 4 (range: 1-11).
Eighty-eight percent of patients met the definition of Rituximab
refractory (defined as no response or a response of less than 6 months in
duration). In patients with
Rituximab refractory disease, 63 percent of patients had a response to
BEXXAR, with a median duration of response of 25 months.
Twenty-nine percent of patients had a complete response (no
clinical signs of disease) to BEXXAR.
The median duration of complete responses has not been reached
after a median follow up of 26 months.
The
results of this study were supported by demonstration of durable objective
responses in four other single-arm studies enrolling 190 patients with
Rituximab-naïve, follicular NHL, with or without transformation, who had
relapsed following or were refractory to chemotherapy.
In these studies, the overall response rates ranged from 47 percent
to 64 percent and the median durations of response ranged from 12 to 18
months. Treatment and Side Effects Bexxar is given intravenously once a week for two weeks. The most common side effects occurring in the clinical trials included neutropenia, thrombocytopenia and anemia that can be both prolonged and severe. Of 230 patients included in the safety data from five clinical trials, 63 percent had documented Grade 3 or 4 neutropenia, 53 percent had Grade 3 or 4 thrombocytopenia, and 29 percent had Grade 3 or 4 anemia. Twenty-seven percent of patients received one or more blood transfusions or blood cell growth factors, eight percent of patients experienced a serious infection and 12 percent experienced bleeding events; the majority were mild to moderate. The most common non-hematologic side effects included asthenia (weakness), fever, nausea, infection and cough. The BEXXAR therapeutic regimen was associated with a risk of hypothyroidism and human anti-murine antibody (HAMA) formation. Certain chemotherapy agents and ionizing radiation have been associated with the development of myelodysplasia (MDS), secondary leukemia and solid tumors. MDS, secondary leukemia and solid tumors have also been observed in patients receiving the BEXXAR therapeutic regimen. BEXXAR carries a warning about infusion-related reactions that may be induced by the administration of foreign proteins. Hypersensitivity reactions occurred in six percent of patients. Adjustments of the rate of infusion to control adverse reactions occurred in seven percent of patients. Links for more information on Bexxar:
Multimedia Resources
Experiences
Joint Manufacturers:
In the UK: 020 8047 5000 In the US: 888 825 5249
For more information on Adult Non-Hodgkin's Lymphoma, please see the following pages: :
Other pages you may want to visit: BEXXAR is a registered trademark of Corixa. This page is a work in progress - if you have more complete information, references, or other information please contact the author. The author is not in the medical field and does not warrant the correctness of the material on this page or the sites linked - please take online information and consult with your own medical team to make informed decisions. Copyright © 1998-2006 Lymphoma Information
Network - All Rights Reserved |
||
 |
