Rituxan Gains Indication for Severe Vasculitis

RITUXAN (rituximab) 10mg/mL solution for IV infusion by Genentech
RITUXAN (rituximab) 10mg/mL solution for IV infusion by Genentech
The FDA has approved Rituxan (rituximab; Genentech) in combination with corticosteroids for the treatment of adults with Wegener's granulomatosis and microscopic polyangiitis, two forms of severe ANCA-associated vasculitis. This approval was based on data from a multicenter, randomized, double-blind, active-controlled study known as RAVE (Rituxan in ANCA-Associated Vasculitis) sponsored by the National Institutes of Health. In the Rituxan group, 64% (63/99) of patients reached the primary endpoint of complete remission at six months, defined as a zero score on the Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG), and successfully tapered off corticosteroids, compared with 53% (52/98) of patients who received cyclophosphamide (the current standard of care) with corticosteroids.

Rituxan is already indicated for the treatment of previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as a single-agent maintenance therapy; on-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy; previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens; previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC); and moderately-to-severely active rheumatoid arthritis in combination with methotrexate in adult patients who have had inadequate response to one or more TNF antagonist therapies.  

For more information call (800) 821-8590 or visit www.rituxan.com.