Roche receives CHMP recommendation for new MabThera indication

Roche has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended regulatory approval of a new indication for MabThera.

A subcutaneous (SC) formulation of the drug has been endorsed for the treatment of patients with common forms of non-Hodgkin lymphoma by the European Medicines Agency committee.

Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. By contrast, the new formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose.

Positive data from the phase III Sabrina trial has demonstrated the safety and efficacy of the subcutaneous product, which has the potential to minimise pharmacy preparation time and overall impact on hospital resources.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike."

MabThera has been available in the EU since its approval in 1998. It is sold under the name Rituxan in the US.