Genentech, a member of Roche (RHHBY), announced that the FDA has approved CD20xCD3 bispecific Lunsumio Velo as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio Velo is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.
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