New therapy regimen approved for advanced follicular lymphoma

On Friday, Jan. 28, the Food and Drug Administration approved the use of Rituxan (rituximab) as a maintenance therapy for advanced follicular lymphoma, a type of non-Hodgkin lymphoma. Follicular lymphoma is typically incurable, with patients frequently relapsing and requiring additional treatments. Rituxan was initially approved in 1997 for non-Hodgkin lymphoma. Since then, it has also been approved for five other indications, including chronic lymphocytic leukemia. Friday's approval is specifically for patients with advanced FL who responded to initial treatment with Rituxan plus chemotherapy (induction treatment) to reduce the risk of relapse and prolong remission. Initially presented at the annual meeting of the American Society of Clinical Oncology this past summer and with follow-up data presented at the annual meeting of the American Society of Hematology in December, data showed that patients with advanced FL do better with ongoing Rituxan given every two months for two years. In the phase 3 trial (called PRIMA or Primary Rituxan and Maintenance), researchers compared 28 months of Rituxan to the traditional four months in 1018 patients with newly diagnosed disease. All patients received chemotherapy and induction therapy of four months of Rituxan, then randomized to either an observation arm or continued therapy for an additional two years of Rituxan. After a median follow-up of three years, researchers found that maintenance therapy increased progression-free survival from 60.3 percent to 78.6 percent. More patients also had complete remission, 55 percent of patients in the observation arm compared with 75 percent on maintenance therapy. Side effects were increased with the longer therapy, particularly infection and decreased white blood cell counts.