Rituxan: Additional Phase III data

Additional data from the open-label, international Phase III CLL8 trial in 817 patients showed that significantly more patients treated with first-line rituximab plus chemotherapy were alive at 37.7 months of follow-up vs. chemotherapy alone (87.2% vs. 82.5%, p=0.012). Also at this time point, median PFS was 51.8 months for rituximab vs. 32.8 months for chemotherapy alone (p<0.001). Data were presented at the American Society of Hematology meeting in New Orleans. Last year, the companies reported that rituximab plus chemotherapy met the primary endpoint of significantly increasing PFS vs. chemotherapy alone (see BioCentury, Jan. 28, 2008; Dec. 8, 2008; & Dec. 22, 2008).

Rituximab is approved to treat non-Hodgkin's lymphoma (NHL). The drug is also approved to treat rheumatoid arthritis in combination with methotrexate in the U.S. and CLL in combination with chemotherapy in the EU. Last month, FDA issued a complete response letter for a pair of sBLAs for rituximab to treat first-line and relapsed CLL (see BioCentury, Nov. 23). ...