The Food and Drug Administration has approved a first-line maintenance indication for rituximab in advanced follicular lymphoma, according to an announcement by Genentech and Biogen Idec.
The indication specifies that maintenance rituximab (Rituxan) may be used in patients with advanced follicular lymphoma who responded to induction treatment with rituximab plus chemotherapy. The European Commission approved the same indication in October 2010, according to the January 28 announcement.
The application for a maintenance rituximab treatment was supported by results of the phase III PRIMA study, a randomized international trial conducted by the Groupe d’Etude des Lymphomes de l’Adulte (GELA). The trial in 1,217 patients with advanced follicular lymphoma not previously treated showed that two years of maintenance therapy cut their risk of relapse in half compared with observation
GELA, the European Organisation for Research and Treatment of Cancer (EORTC)’s adult lymphoma study group, had reported the progression-free survival rate among 505 patients randomized to maintenance with rituximab (Rituxan in the United States, MabThera in Europe) was 82% at 2 years vs. 66% for 513 patients randomized to observation only (hazard ratio 0.50, stratified log-rank, P less than .0001). Rituximab maintenance reduced by 39% the need for patients to be started on new antilymphoma therapies (HR 0.61, P less than .0003), according to GELA’s presentation at the American Society for Clinical Oncology’s 2010 annual meeting.
All patients in the trial received rituximab in their induction regimens: 75% had R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone); 22% R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisone), and 3% R-FCM (rituximab plus fludarabine, cyclophosphamide, and mitoxantrone). Patients randomized to maintenance rituximab received it for 2 years as a single agent.
Investigators said rituximab maintenance was generally well tolerated, with grade 3 or 4 adverse events occurring in 22% of patients. The most common were infections in 37% of patients on maintenance and 22% of those on observation. Grade 3 or 4 neutropenia and low white blood cell count each occurred in about 4% of patients on maintenance rituximab.
The trial was sponsored by Roche, which markets rituximab outside the United States and is the parent company of Genentech.