CHMP recommends approval of subcutaneous MabThera for NHL-Roche
The EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection, from Roche, for the treatment of patients with common forms of Non-Hodgkin Lymphoma (NHL). Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours.
The new MabThera SC formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources. The CHMP opinion is based primarily on data from the Phase III SABRINA study. Roche expects a final decision from the European Commission in the coming months.
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