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news.The FDA has approved GlaxoSmithKline's supplemental biologics license application for expanded, earlier, use of the Bexxar therapeutic regimen in non-Hodgkin's lymphoma.
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The supplemental biologics license application (sBLA) was filed on July 1, 2004, and was granted priority review status. The expanded indication will make Bexxar an earlier option for patients with relapsed low-grade or follicular non-Hodgkin’s lymphoma.
The Bexxar therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is now indicated for the treatment of patients with CD 20 antigen expressing relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin’s lymphoma, including patients with Rituximab-refractory non-Hodgkin’s lymphoma.
The original indication specified that patients have disease that was refractory to Rituximab and had relapsed following chemotherapy.
Determination of the effectiveness of the Bexxar therapeutic regimen was based on overall response rates in patients whose disease is refractory to chemotherapy alone or to chemotherapy and Rituximab. The effects of the Bexxar therapeutic regimen on survival are not known and the safety of multiple courses of the regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.
“We are pleased that the FDA has moved so quickly to make Bexxar available to a larger group of patients,” said Kevin Lokay, vice president of oncology and acute care at GlaxoSmithKline.
“This expanded indication establishes Bexxar as an important alternative for initial treatment of relapsed disease. Now clinicians will be able to offer the potential benefits of Bexxar earlier in the treatment course for their patients with non-Hodgkin’s lymphoma, and not have to wait for their disease to become refractory,” Lokay stated.