European Commission Approves Injectable Rituximab for Chronic Lymphocytic Leukemia

The European Commission approved subcutaneous rituximab for the treatment of previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL).

The approval was based the results of the phase Ib SAWYER study that included untreated CLL patients who received 1,600 mg of subcutaneous rituximab or 500 mg/m2 of rituximab administered intravenously in combination with fludarabine and cyclophosphamide. Patients in each group had comparable levels of serum concentrations, as well as similar efficacy and safety.

Source: Roche media release, May 31, 2016.