Rituxan approved for chronic lymphocytic leukemia

The 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.