Rituxan sBLA seeks NHL combo claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genentech's Horizon 2010 strategy progresses with the March 29 sBLA submission of Rituxan (rituximab) for front-line treatment of previously untreated non-Hodgkin's lymphoma in combination with two chemotherapeutic regimens. The application is based on two pivotal trials in 644 treatment-experienced patients and proposes use of Rituxan in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) regimens, or following CVP in responders. The submission follows two supplemental approvals for Rituxan in February: one for rheumatoid arthritis and an expansion of the biologic's front-line diffuse large B-cell, NHL indication (1Pharmaceutical Approvals Monthly March 2006, p. 14). The Horizon 2010 strategy calls for Genentech to gain FDA clearance for at least 15 new indications or products by 2010...