Roche: MabThera receives positive opinion in Europe for treating patients whose chronic lymphocytic leukaemia returns
Patients with relapsed or refractory disease can live ten months longer without their disease progressing
Roche announced that the European Union’s Committee on Human Medicinal Products (CHMP) has issued a positive recommendation for the use of MabThera (rituximab) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). Physicians will soon be able to prescribe MabThera, the first monoclonal antibody therapy approved for previously untreated CLL, in combination with chemotherapy to patients who have been treated for the disease but whose cancer has returned or have not appropriately responded to therapy.
This recommendation is based on the important results from REACH, the largest randomised clinical trial ever reported in previously treated CLL. These results showed that patients with relapsed or refractory CLL who received 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). MabThera is already approved for first-line use in previously untreated CLL in the EU and many other countries and, pending final approval by the EU authorities, physicians will be able to prescribe MabThera to those patients with relapsed or refractory disease.
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