Roche announced that the US Food and Drug Administration (FDA) approved Rituxan/MabThera (rituximab) plus fludarabine and cyclophosphamide (FC) chemotherapy for people with either previously untreated (first-line) or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukaemia (CLL).

CLL is the most common type of leukaemia in adults, accounting for approximately 30-40 per cent of all forms of leukaemia in Western countries. Overall incidence of CLL is around four per 100,000 and is 50 per cent more common in men than in women. CLL is currently considered incurable; therefore the aim of treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening (progression-free survival or PFS).

Pivotal studies have shown that patients with CLL who are treated with Rituxan/MabThera plus chemotherapy live significantly longer without their disease progressing than those treated with chemotherapy alone. In addition, new data from one of the pivotal trials show that first-line treatment with Rituxan/MabThera (plus chemotherapy) improves overall survival, positively affecting for the first time the natural course of CLL. These latter data from the pivotal CLL8 phase III study were presented in December 2009 at the 51st annual meeting of the American Society of Haematology (ASH) in New Orleans, LA (USA).

"The approval of Rituxan/MabThera in combination with chemotherapy for the treatment of CLL gives hope to the thousands of US patients living with this devastating disease, and reinforces the role that this medicine plays in treating blood cancers," said Pascal Soriot, COO Roche Pharmaceuticals Division. "Rituxan/MabThera is already standard of care for Non-Hodgkin's lymphoma, a group of cancers that affect the lymphatic system."

In 2009, Rituxan/MabThera was approved in the European Union for use in combination with chemotherapy in previously untreated patients (first line) with advanced CLL and those with relapsed or refractory CLL.

Rituxan/MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells.