Roche's (RHHBY.US) Subcutaneous Injection of Moxetumomab Pasudotox approved for market launch

On November 19, Roche (RHHBY.US) announced that the conditional marketing authorization application for Lunsumio (mosunetuzumab, an anti-CD20/CD3 T cell engager) subcutaneous (SC) injection has been approved by the European Commission (EC) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) adult patients who have received at least second-line systemic therapy. Mosunetuzumab is a bispecific T cell engager (TCE) developed by Roche that targets CD20 and CD3, activating and redirecting the patient's existing T cells to release cytotoxic proteins into B cells, thereby activating and eliminating target B cells. The intravenous (IV) formulation of mosunetuzumab was approved for marketing in the EU in June 2022. The SC formulation approved this time can be used in outpatient settings, with injection time only requiring 1 minute, significantly shorter than the time needed for the IV formulation (2-4 hours).