FDA approves Roche's Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse Basel, 22 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) 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. “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche's Chief Medical Office
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