FDA APPROVES NEW INDICATIONS FOR RITUXAN

Genentech and Biogen Idec announced that the FDA has approved two additional uses for Rituxan (Rituximab) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). One new indication for Rituxan is for first-line treatment of previously untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.

The first new approval is based on data from a Phase III, randomized, controlled study of 322 patients. The study evaluated the first-line use of Rituxan in combination with CVP chemotherapy (R-CVP) versus CVP chemotherapy alone. All patients received up to eight three-week cycles of CVP chemotherapy. Patients in the R-CVP arm received Rituxan 375 mg/m2 on day one of each treatment cycle. The second new approval is based on a Phase III, randomized, controlled Eastern Cooperative Oncology Group study of 322 patients. Study participants received Rituxan 375 mg/m2 given in four weekly infusions every six months for up to 16 doses, or observation. Rituxan reduced the risk of disease progression, relapse or death by more than 50 percent over observation.

In February Rituxan in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy was approved as first-line treatment for patients with diffuse large B-cell lymphoma. The drug was approved in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD20- positive B-cell NHL.