Genentech and Biogen Idec file supplemental biologics license application for Rituxan

Genentech, Biogen Idec and Roche have filed a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for an additional indication for Rituxan in previously untreated patients with certain forms of non-Hodgkin's lymphoma (NHL) in combination with other anthracycline-based chemotherapy regimens.

As part of the filing, the companies have requested Priority Review designation from the FDA. The filing applies to intermediate grade or aggressive, CD-20-positive, B-cell NHL in combination with, for example, CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone). It is based on data from three Phase III trials in more than 1,800 Patients

Rituxan (rituximab) is currently approved for use in relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma.

Biogen Idec's executive vice-president of development Burt Adelman said: 'The addition of Rituxan to CHOP represents the first significant improvement in intermediate grade or aggressive CD-20-positive, B-cell NHL treatment since the development of the CHOP regimen more than 30 years ago.'

There are currently more than 360,000 people in the US living with NHL. Approximately 50% have aggressive NHL, while the other half are patients with indolent or follicular lymphoma.