FDA Approves Rituxan as Maintenance Treatment for Advanced Follicular Lymphoma

Strategic Insights -

Advanced follicular lymphoma patients who responded to initial treatment with Rituxan and chemotherapy now have a new maintenance option to prolong time without disease worsening. The FDA approval of Rituxan as a single-agent maintenance therapy for patients with advanced follicular lymphoma was based on data from the Phase III PRIMA study. The study showed that patients who received Rituxan every two months for two years after initial treatment had nearly double the likelihood of living without disease progression compared to those who stopped treatment. This milestone follows the European Commission's clearance of Rituxan for this indication in October 2010.

Key Takeaways:

  • Rituxan has been approved by the FDA as a single-agent maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan and chemotherapy.
  • The approval was based on data from the Phase III PRIMA study, which showed that patients who received Rituxan every two months for two years had nearly double the likelihood of living without disease progression.
  • The safety profile of Rituxan as maintenance therapy was consistent with those previously reported in pivotal studies of Rituxan alone or in combination with chemotherapy.
  • Common side effects of Rituxan included infusion reactions, fever, chills, low white blood cells, infections, body aches, and tiredness.
  • Rituxan is also approved for the treatment of non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy.
  • Genentech and Biogen Idec collaborate on Rituxan in the United States, while Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
  • Rituxan can cause serious side effects, including infusion reactions, tumor lysis syndrome, and progressive multifocal leukoencephalopathy.

Statistics:

  • 1,217 patients were enrolled in the PRIMA study, a Phase III clinical trial evaluating the efficacy and safety of maintenance Rituxan in patients with previously untreated advanced follicular lymphoma.
  • Patients who received Rituxan maintenance had a nearly double likelihood of living without disease progression compared to those who stopped treatment (hazard ratio of 0.54, 95% CI, 0.42-0.70; p 2%) in the Rituxan group included infections (4% vs. 1%) and low white blood cell count (4% vs. 1%).

Sources:

  • Business Wire
  • Genentech press release
  • Biogen Idec press release
  • FDA approval letter for Rituxan as maintenance treatment for advanced follicular lymphoma