Roche Wins US FDA Approval for Lymphatic Cancer Drug

MT Newswires · 2d ago
01:38 AM EST, 12/22/2025 (MT Newswires) -- Roche's (ROG.SW) Lunsumio Velo, or mosunetuzumab, secured approval from the US Food and Drug Administration for the treatment of adult follicular lymphoma patients. Lunsumio Velo has been approved as a subcutaneous formulation for patients who have two or more lines of systemic therapy, the Swiss drugmaker said Monday. Full approval will require confirmation of the benefits in a confirmatory trial. According to the results of GO29781 study, the drug reduced administration time to one minute from two to four hours of intravenous infusion. In patients with third-line or later follicular lymphoma, the drug's objective response rate and complete response rate were 75% and 59%, respectively, with a median response duration of 22.4 months.