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December 22, 2022December 22, 2022 - Genentech, a member of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio ® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy that contains mosunetuzumab, a first-in-class bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells. It works by activating and redirecting the T cells to engage and eliminate the target B cells. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Lunsimio is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks.