www.fdanews.com/articles/67189-gsk-gains-expanded-indication-for-bexxar
GSK GAINS EXPANDED INDICATION FOR BEXXAR
January 5, 2005
GlaxoSmithKline (GSK) has received FDA approval to expand the use of its cancer drug Bexxar to patients with non-Hodgkin's lymphoma (NHL).
The FDA-approved supplemental biologics license application allows GSK to market Bexxar (tositumomab and iodine I 131 tositumomab) for treatment of patients with CD 20 antigen expressing relapsed or refractory, low-grade, follicular, or transformed NHL, including patients with rituximab-refractory NHL.
The drug's original indication specified that patients must be refractory to rituximab and have relapsed following chemotherapy.