MabThera rituximab regulatory update

The U.K.'s NICE issued final guidance recommending MabThera rituximab from Roche in combination with glucocorticoids to induce remission in adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, also known as severely active granulomatosis with polyangiitis and microscopic polyangiitis. NICE only recommends MabThera if further cyclophosphamide treatment would exceed the maximum cumulative cyclophosphamide dose; if cyclophosphamide is not suitable; if patients want children and cyclophosphamide might affect their fertility; if the disease has stayed active or got worse after a 3-6 month course of cyclophosphamide; or if the person has had uroepithelial malignancy. The guidance is in line with a final appraisal determination issued in January (see BioCentury, Oct. 21, 2013). Roche did not submit a patient access scheme. ...