MAINTENANCE RITUXIMAB IN FOLLICULAR LYMPHOMA APPROVED

January 31, 2011 — The US Food and Drug Administration (FDA) has approved the CD20-directed monoclonal antibody rituximab (Rituxan, Roche) as a single-agent maintenance treatment for patients with previously untreated advanced follicular lymphoma who responded to initial treatment with rituximab plus chemotherapy.
The approval, given on January 28, was based on the Primary Rituxan and Maintenance (PRIMA) study, which found that rituximab administered every 2 months for 2 years in patients who responded to initial treatment with rituximab plus chemotherapy nearly doubled the likelihood of progression-free survival compared with in patients who received no maintenance therapy (hazard ratio, 0.54; 95% confidence interval, 0.42 - 0.70; P ≤ .0001).
The phase 3 study, conducted by the Groupe d'Etude des Lymphomes de l'Adulte, is an international, multicenter, randomized, phase 3 clinical study. A total of 1217 patients with previously untreated advanced follicular lymphoma were included in the analysis.
Patients received as initial therapy 8 cycles of rituximab plus chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone; cyclophosphamide, vincristine, and prednisone; or fludarabine, cyclophosphamide, and mitoxantrone. The 1018 patients who responded were randomly assigned to receive rituximab as single-agent maintenance, given once every 2 months for 2 years or to observation alone.
The safety profile was as expected and was consistent with previous studies. Infections of grade 2 or higher were reported more frequently in patients who received maintenance compared with the patients in the observation group (37% vs 22%). Grade 3 to 4 adverse reactions that occurred more frequently with maintenance therapy included infections (4% vs 1%) and low white blood cell count (4% vs <1%).
"This approval is important because it shows that maintenance treatment with Rituxan, after initial therapy with Rituxan and chemotherapy, further reduces the risk of relapse in people with follicular lymphoma," noted Hal Barron, MD, chief medical officer and head, Global Product Development, Roche, in a company written release.
Rituxan received FDA approval for rheumatoid arthritis in February 2006 and is currently indicated in combination with methotrexate in adult patients with moderately to severely active rheumatoid arthritis who have had inadequate response to one or more tumor necrosis factor antagonist therapies.