Rituximab Gains Nod for Maintenance Therapy in Follicular Lymphoma
Rituximab (Rituxan) was approved by the FDA as a maintenance treatment for patients with advanced follicular lymphoma (FL) who responded to initial treatment with rituximab plus chemotherapy.
The approval was based on data from the phase 3 PRIMA study, an international, multicenter, randomized study that enrolled 1217 patients with previously untreated advanced FL.
By continuing rituximab every 2 months for 2 years in patients who responded to initial rituximab plus chemotherapy treatment, progressionfree survival was nearly doubled compared with those who stopped treatment (P <.001).
The safety profile was consistent with those previously reported in pivotal studies of rituximab alone or in combination with chemotherapy.
Grade 2 or higher infections were reported more frequently in patients who received rituximab maintenance compared with the observation arm (37% vs 22%) for both. (January 28, 2011)