Roche submits extension application to EMA for subcutaneous MabThera

Roche has submitted a line extension application to the European Medicines Agency for a subcutaneous (SC) formulation of MabThera (rituxumab) for patients with Non-Hodgkin Lymphoma. Currently, MabThera is available as an IV formulation. The application is backed by pivotal study data which showed that SC administration of MabThera enabled the delivery of MabThera over approximately five minutes without compromising its proven efficacy and safety.

Both studies showed that a fixed dose of MabThera can be administered subcutaneously, potentially allowing patients to spend less time in infusion centers receiving their MabThera treatment. Specifically, the studies showed that SC injection resulted in non-inferior MabThera concentrations in the blood (pharmacokinetics; PK) compared with standard intravenous (IV) infusion. Overall, SC and IV adverse event profiles were similar and administration related reactions were mostly of mild to moderate intensity.