NCI Cancer Bulletin for February 8, 2011 - National Cancer Institute: Rituximab Approved as Maintenance Therapy for Follicular Lymphoma

Rituximab Approved as Maintenance Therapy for Follicular Lymphoma

On January 28, the FDA approved rituximab (Rituxan) as a maintenance therapy for patients with follicular lymphoma who responded to initial treatment with rituximab in combination with chemotherapy. The approval is the drug’s sixth cancer indication since it was initially approved in 1997 as a second-line treatment for non-Hodgkin lymphoma (NHL). In addition to several NHL indications, rituximab is also approved for the treatment of chronic lymphocytic leukemia.

The FDA granted the new indication based on the international phase III PRIMA trial, which involved 1,200 patients. Those in the trial who responded to initial treatment with rituximab and chemotherapy, and who continued to receive rituximab every 2 months for the next 2 years, had a 46 percent improvement in progression-free survival compared with patients who did not receive the maintenance therapy. After 2 years, 82 percent of patients in the maintenance therapy arm compared with 66 percent of patients in the control arm were still alive with no progression of their disease.

The PRIMA trial results were presented last year at the American Society of Clinical Oncology’s annual meeting.

NCI Cancer Bulletin for February 8, 2011 - National Cancer Institute