EU approves subcutaneous formulation of MabThera for Follicular Lymphoma and NHL- Roche/Genentech
Roche has announced that the European Commission (EC) has approved . on 28 March 2014 ,a new subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients with Follicular Lymphoma and diffuse large B-cell Lymphoma (Non Hodgkin Lymphoma). Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche�s oncology products. The new formulation, which was approved to treat some patients with non-Hodgkin lymphoma, cuts the treatment time from two-and-a-half hours for the original intravenous version to 5 minutes.
The European approval was based primarily on data from the pivotal SABRINA study, which was recently published in The Lancet Oncology.
See- Davies, A. et al. (2014) Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study The Lancet Oncology, Early Online Publication, 10 February 2014 doi:10.1016/S1470-2045(14)70005-1
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