Genentech (Roche) has received accelerated approval from the FDA for Lunsumio VELO (mosunetuzumab-axgb) as a subcutaneous injection for the treatment of adult patients with relapsed or refractory follicular lymphoma following two or more lines of systemic therapy[2]. The approval is based on the results of the Phase I/II GO29781 study, which evaluated Lunsumio VELO in patients in the 3rd line and above[2][3]. In the primary analysis of the GO29781 trial, the treatment achieved an objective response rate of 75% (95% CI: 64-83%) and a complete response rate of 59% (95% CI: 48-69%) in patients with 3L+ FL[3][5]. The subcutaneous formulation reduces the administration time from the usual 2-4 hours for intravenous administration to approximately one minute[2][5]. Lunsumio VELO was granted under accelerated approval; full approval may be conditional on confirmation of benefit in a confirmatory study[2][3]. Administration is of fixed duration and can be performed in the outpatient setting similar to intravenous Lunsumio[5]. The safety profile included manageable cases of cytokine release reaction, according to company and expert announcements cited in the approval[2][4]. This subcutaneous formulation is also the subject of further research in combinations and in other B-cell non-Hodgkin's lymphomas[3][5].