Radioimmunotherapy Drug Receives Expanded Label Approval 
The radioimmunotherapy drug ibritumomab tiuxetan (Zevalin) received expanded label approval from the United States Food and Drug Administration (FDA) for the treatment of patients with previously untreated follicular non-Hodgkin lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. This therapy targets CD20 markers which are found on the surface of some lymphoma cells and delivers radiation.
Originally approved in 2002 by the FDA for the treatment of patients with relapsed (disease returns) or refractory (disease does not respond to treatment), low-grade or follicular B-cell non-Hodgkin lymphoma, the new indication was granted following the data from the First-line Indolent Therapy (FIT) Study. Results of the 414 patients with CD20-positive follicular NHL who reached a partial or complete response after receiving chemotherapy on the study (numerous types of chemotherapy were used in this study) were presented at the 2008 annual meeting of the American Society of Hematology. The results of this study were statistically significant, which means that the average progression-free survival was better for the patient population who received ibritumomab tiuxetan plus chemotherapy, as compared to the patients in the study who received chemotherapy alone.
"This approval means specifically that patients will be able to receive ibritumomab tiuxetan (Zevalin) to consolidate a response after chemotherapy for follicular lymphoma. More importantly, however, the approval represents an acknowledgement that radioimmunotherapy (Zevalin or Bexxar) has important activity and is beneficial for many patients with follicular lymphoma, for indications that have been approved since 2002. Hopefully, oncologists will now recognize the potential benefit of this form of treatment for patients who are in first or second relapse," says Leo I. Gordon, MD of Robert H. Lurie Comprehensive Center of Northwestern University.
Ibritumomab tiuxetan (Zevalin) represents one of two drugs in the radioimmunotherapy class of treatments for lymphoma. The other drug, tositumomab (Bexxar) is approved for the treatment of patients with relapsed (disease returns) or refractory (disease does not respond to treatment), low-grade or follicular B-cell non-Hodgkin lymphoma. For more information on any of these treatments, please contact the Lymphoma Helpline at (800) 500-9976 or helpline@lymphoma.org.
Stay tuned for an update on radioimmunotherapy in the next issue of LRF's newsletter, Lymphoma Today.
9/17/09
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