Roche’s MabThera approved in new subcutaneous formulation

Roche has announced that a new subcutaneous formulation of its cancer therapy MabThera has been approved by the European Commission.

This new version of MabThera is indicated for people with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. It marks the second approved indication for the drug, which was ratified for the treatment of non-Hodgkin lymphoma in 2014.

The decision was based on positive data from the phase Ib SAWYER study, which showed a comparable level of safety and efficacy between subcutaneous and intravenous MabThera in combination with chemotherapy.

It is expected that the subcutaneous formulation of MabThera could help to save time and ease the burden of treatment compared with the intravenous form.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "MabThera SC provides patients with significantly faster treatment administration and the opportunity to enjoy more time outside the clinical setting compared to intravenous delivery of the medicine."