Genentech/Biogen Idec submit Rituxan sBLA

US biotechnology firms Biogen Idec and Genentech, which is majority-owned by Swiss drug major Roche, have submitted a supplemental Biologics License Application to the Food and Drug Administration for the use of Rituxan (rituximab) as first-line treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with cyclophosphamide, vincristine and prednisone (CVP) or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy or following CVP chemotherapy in those patients who achieved a response of stable disease or better.

The submission is primarily based on efficacy and safety data from two randomized, controlled studies of Rituxan in 644 previously-untreated patients, the first of which was a Phase III 322-patient trial in follicular, CD20-positive, B-cell NHL that met its primary endpoint of an improvement in progression-free survival in combination with CVP chemotherapy versus CVP chemotherapy alone.

Rituxan is already approved as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL. The drug, in combination with CHOP or other anthracycline-based chemotherapy, was approved in February as first-line treatment for patients with diffuse large B-cell lymphoma. It is also cleared in combination with methotrexate to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.