The US Food and Drug Administration has approved rituximab (Rituxan, Genentech/Biogen Idec) for maintenance treatment for patients with advanced follicular lymphoma (FL) who responded to induction treatment with rituximab plus chemotherapy.
Approval was based on results of the phase 3 Primary Rituxan and Maintenance (PRIMA) study, which enrolled 1217 patients with untreated FL. Patients received eight cycles of cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP), cyclophosphamide/vincristine/prednisone (CVP), or fludarabine/cyclophosphamide/mitoxantrone (FCM). If they responded to induction treatment, they were randomized to maintenance rituximab (once every 2 months for 2 years) or observation.
Progression-free survival nearly doubled in the maintenance group (hazard ratio, 0.54; 95% confidence interval, 0.42-0.70; P ≤.0001). Grade 3/4 infections and low white blood cell counts occurred at a higher rate in the maintenance group.