The EU Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve Roche's MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL).
At present, the drug is delivered by an intravenous infusion which takes approximately 2.5 hours, while the new MabThera SC formulation can be delivered about five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources.
Roche chief medical officer and head of Global Product Development Sandra Horning said the company is happy that the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time.
"We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike," Horning added.
The opinion is based mainly on data secured from the Phase III SABRINA trial and the company expects a final decision from the European Commission in the coming months.
MabThera is a therapeutic monoclonal antibody that binds to a particular protein, the CD20 antigen, on the surface of normal and malignant B-cells.
