European regulators have approved rituximab (MabThera or Rituxan) as a first-line maintenance treatment for patients with follicular lymphoma (FL) whose disease has responded to initial induction therapy.
Approval was based on results from the Roche gains OK in Europe for rituximab for maintenance late-stage PRIMA study, which randomized 1,217 patients with previously untreated advanced FL to rituximab plus CHOP, CVP, or FCM chemotherapy for initial treatment. Patients who responded (1,018/1,217) were randomized to receive rituximab alone, given once every two months for two years as maintenance, or observation alone (ASCO 2010 abstract 8004). PRIMA demonstrated that continuing rituximab for two years in patients who responded to initial rituximab plus chemotherapy doubled the likelihood of progression-free survival compared with observation. At two years’ follow up, 82% of patients on maintenance were in remission.