Roche announced that the European Commission (EC) has approved MabThera (rituximab) for use in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL), the most common form of the disease in adults. The approval is supported by the impressive results from REACH, the largest randomised clinical trial ever reported in previously-treated CLL. Physicians can now prescribe MabThera in combination with chemotherapy to patients who have been treated for the disease but whose cancer has returned or who have not responded appropriately to therapy. MabThera is already the standard of care for initial treatment of CLL.
"This approval will make MabThera plus chemotherapy the gold-standard therapy for people living with relapsed or refractory CLL," said professor Tadeusz Robak, Medical University of Lodz, Poland and principal investigator for the REACH trial. "Although all patients with CLL will unfortunately eventually relapse, treatment with MabThera significantly prolongs remission. This will help ease the burden of the cancer and enable patients to enjoy the relative freedom that comes with this relief from symptoms."
The results of REACH showed that patients with relapsed or refractory CLL who were treated with MabThera in combination with chemotherapy lived an average ten months longer without their disease progressing, compared to those receiving chemotherapy alone (30.6 months vs. 20.6 months). At present, CLL is considered incurable and the aim of treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening.
"Today's approval of MabThera in CLL throws a life line to patients suffering from this terrible disease," said William M Burns, CEO, Roche Pharmaceuticals Division. "After the approval for use in patients with previously untreated CLL earlier this year, this latest license extension means that MabThera can now offer real hope to all patients with 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 three per 100,000 and is 30 per cent more common in men than women. The incidence of CLL is markedly increased in patients older than 65 with a median age at diagnosis of 72 years. While CLL is generally considered a disease that is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.
Earlier this year, Roche received marketing approval for MabThera in combination with chemotherapy in previously-untreated patients with advanced CLL.
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells.