SUMMARY: The FDA in January, 2011 approved rituximab (RITUXAN®) as a maintenance treatment for patients with advanced follicular lymphoma. Follicular lymphomas are a subset of Non Hodgkins Lymphomas and are very responsive to chemotherapy or chemotherapy given along with RITUXAN®. They are however incurable, despite treatment with RITUXAN® plus chemotherapy. This condition can therefore be considered as a chronic disease. For this reason, prolonging remission duration is important, as the length of remission tends to be shorter with each recurrence. The FDA approval was based on the PRIMA trial, which is a phase III study, in which 1217 treatment naive patients with stage III and stage IV disease requiring therapy were initially treated with RITUXAN® and chemotherapy (induction chemotherapy). Patients responding to initial therapy (n = 1018) were randomized to observation alone or maintenance RITUXAN® for 2 years. The first preplanned interim analysis at a median follow up of 25 months demonstrated a progression-free survival (PFS) of 82% in the RITUXAN® maintenance therapy group versus 66% for those in the observation group, which meant that the recurrence rate was 18% with RITUXAN® maintenance versus 34% for those who were observed. This benefit with RITUXAN® maintenance therapy was seen regardless of age, disease severity, and type of induction chemotherapy received. These findings are relevant, as these patients essentially have a chronic disease and are willing to pursue interventions that could potentially delay recurrence of their lymphoma and thus improve their quality of lives. J Clin Oncol 28:15s, 2010 (suppl; abstr 8004))
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