10 Dec 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Two studies by Roche has demonstrated that a fixed dose of MabThera (rituximab) can be administered subcutaneously, potentially allowing patients to spend less time at infusion centers receiving their MabThera treatment.
Specifically, the studies showed that subcutaneous injection resulted in non-inferior MabThera concentrations in the blood compared with standard intravenous (IV) infusion. Overall, subcutaneous and IV adverse event profiles were similar and administration-related reactions were mostly of mild to moderate intensity.
"MabThera subcutaneous has the potential to offer patients an effective and more convenient delivery option for MabThera, which has revolutionized the treatment of B-cell malignancies," said Dr Hal Barron, chief medical officer and head, Global Product Development. "As a leader in innovative treatments for cancer, Roche is committed to a broad research program of investigational medicines and innovative ways to administer them."
Administering MabThera subcutaneous shortens the treatment time significantly, enabling administration over approximately five minutes compared with 2.5 hours during IV infusion. The ready-to-use subcutaneous formulation may also significantly reduce pharmacy time and the impact on hospital resources as medicine preparation time and hospital staff time per administration are significantly reduced.
MabThera subcutaneous uses Enhanze Technology, developed by Halozyme Therapeutics, which enables the injection of large volumes of a medication under the skin (subcutaneous). It temporarily modifies a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.
Roche is also developing a subcutaneous formulation of Herceptin (trastuzumab) using this technology and has submitted a line extension application for Herceptin subcutaneous to the European Medicines Agency for the treatment of HER2-positive breast cancer.