Roche's (RHHBY.US) Subcutaneous Mosunetuzumab Approved for Market Launch

Stock News11-19

On November 19, Roche Holding Ltd (RHHBY.US) announced that the European Commission (EC) has granted conditional marketing authorization for the subcutaneous (SC) formulation of Lunsumio (mosunetuzumab). This treatment is approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. Mosunetuzumab is a T-cell engaging (TCE) bispecific antibody developed by Roche, targeting both CD20 and CD3. It works by redirecting and activating the patient's existing T cells to release cytotoxic proteins into B cells, thereby eliminating the targeted B cells. The intravenous (IV) formulation of mosunetuzumab was approved in the EU in June 2022. The newly approved SC formulation can be administered in outpatient settings, with an injection time of just 1 minute—significantly shorter than the 2-4 hours required for IV administration.

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