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U.S. Department of Health and Human Services

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FDA approves two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma

On September 29, 2006, the U.S. Food and Drug Administration approved two rituximab (Rituxan, Genentech, Inc.) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma.  One approval was for the use of Rituxan combined with CVP chemotherapy (cyclophosphamide, vincristine, and prednisone); the second is for use of  Rituxan following CVP chemotherapy.

The first indication was based on a 322 patient study.  Patients had an advanced-stage, follicular, CD20+ NHL and were previously untreated with chemotherapy.  Patients were randomized (1:1) to receive either a maximum of eight 3-week cycles of CVP chemotherapy alone or CVP chemotherapy in combination with Rituxan (375 mg/m2 on day 1 of each 21-day cycle).  Patients receiving Rituxan plus CVP showed a statistically significant improvement in progression-free survival compared to those receiving CVP alone (median PFS 2.4 vs. 1.4 years; hazard ratio 0.44, p<0.0001 two-sided stratified log rank test).

The second indication was based on a 322 patient trial enrolling previously untreated low-grade, B-cell NHL (IWF Grades A, B or C) patients with stable disease or partial or complete responses following 6-8 CVP chemotherapy cycles.  Patients were randomized (1:1) to receive either no additional therapy or Rituxan (375 mg/m2 once weekly for 4 doses) every 6 months for up to 16 doses.  A statistically significant reduction in PFS was observed; the hazard ratio for reduction in the risk of progression, relapse, or death ranged from 0.36 to 0.49 for Rituxan versus those who received no additional treatment.

The safety profile observed in these trials was consistent with the previously described safety profile provided in the product label.  Full prescribing information is available 

in Drugs@FDA

                                                                                                               
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178 by mail using the Form 3500 

 

 

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