February 19, 2010
Rituxan approved for chronic lymphocytic leukemiaThe FDA has approved Rituxan (rituximab, from Genentech) in combination with fludarabine and cyclophosphamide (FC) for patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). This approval was based on data from two Phase 3, international, multicenter, randomized, open-label studies: CLL8 and REACH. CLL8 enrolled 817 patients with previously untreated CD20-positive CLL whereas REACH enrolled 522 patients with previously treated, Rituxan-naïve, CD20-positive CLL.
In CLL8, patients who received Rituxan plus FC had a 79% improvement in the time patients lived without their disease getting worse compared to those who received FC alone (p<0.01) and lived a median of 39.8 months without the disease worsening compared to 31.5 months for patients who received FC alone. In REACH, patients who received Rituxan plus FC had a 32% improvement in the time patients lived without their disease getting worse compared to those who received FC alone (p=0.02). Previously treated patients who received Rituxan plus FC lived a median of 26.7 months without the disease worsening compared to 21.7 months for patients who received FC alone.
Rituxan is already indicated for the treatment of relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin's lymphoma (NHL); first-line treatment of follicular, CD20(+), B-cell NHL in combination with CVP chemotherapy; non-progressing (including stable disease), low-grade, CD20(+), B-cell NHL following 1st line CVP chemotherapy; and as first-line treatment of diffuse large B-cell, CD20(+) NHL in combination with CHOP or other anthracycline-based chemotherapy regimens.
For more information call (800) 821-8590 or visit www.rituxan.com.