Roche | MEDIA
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FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma
Roche announced FDA approval of Lunsumio VELO (mosunetuzumab) for relapsed or refractory follicular lymphoma. This subcutaneous formulation reduces administration time to approximately one minute, a significant improvement. The approval is based on the GO29781 study showing high complete response rates in patients with third-line or later disease. Lunsumio VELO is approved under accelerated approval, with full approval pending confirmatory trial results. The drug's manageable cytokine release syndrome profile is an advantage for delivery in community settings. The study results include 75% objective response and 59% complete response rates. Common adverse reactions included injection site reactions and fatigue. This approval broadens access to effective treatments for those living with follicular lymphoma. Lunsumio VELO's fixed-duration treatment contrasts with potentially indefinite "treat-to-progression" options. Roche is also studying Lunsumio and Lunsumio VELO in earlier lines of treatment. This is a step in improving care for those with this chronic disease.