Posted by Michael Wonder on 23 Mar 2018
Health Canada approves Rituxan subcutaneous formulation for Canadians with chronic lymphocytic leukaemia
22 March 2018 - Rituxan SC is a new treatment option for Canadians living with one of the most common forms of leukaemia.
Roche Canada announced today that Health Canada has approved Rituxan (rituximab) subcutaneous (SC) for the treatment of patients with previously untreated or previously treated B-cell chronic lymphocytic leukaemia (B-CLL), Binet Stage B or C, in combination with fludarabine and cyclophosphamide.
The Health Canada approval of Rituxan SC is based on data from the Phase Ib SAWYER study in 176 patients with chronic lymphocytic leukaemia (CLL). The two-part Phase Ib, multicenter, randomised, open-label, parallel-group study was conducted in patients with previously untreated CLL to investigate the non-inferiority of the pharmacokinetic profile, together with efficacy and safety of Rituxan SC in combination with chemotherapy.
