Specifically, the companies are seeking approval for the use of the drug as a treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL).
The supplemental biologic license application is primarily based on efficacy and safety data from two randomized, controlled studies of Rituxan in 644 previously-untreated patients.
Rituxan is already approved as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL.
Rituxan in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy was approved in February as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).
The drug was also approved in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.