FDA
FDA greenlights subcutaneous mosunetuzumab for relapsed/refractory follicular lymphoma
Brand name: Lunsumio VELO
Generic name: mosunetuzumab-axgb
Manufacturer: Genentech
Approval date: Dec 21, 2025
FDA has approved a subcutaneous formulation of mosunetuzumab-axgb, a bispecific antibody targeting CD20 and CD3, for adults with relapsed/refractory follicular lymphoma.
The manufacturer notes that compared with the IV formulation, the subcutaneous formulation reduces administration time from 2-4 hours to about a minute. They report that accelerated approval was granted based on an analysis of phase I/II GO29781 study data on patients with third-line or later follicular lymphoma, which showed objective response rates of 75% and complete response rates in 59%, with median response duration of 22.4 months. Cytokine release syndrome, which can be severe and life-threatening, occurred in 30%; most events were low grade and resolved within a median of two days, according to the manufacturer. Full FDA approval may be contingent upon demonstration of benefit in a confirmatory trial, per Genentech.
Sources:
Lunsumio VELO [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761263s005lbl.pdf. Accessed December 31, 2025.
FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma. [Press release]. 2025. https://www.gene.com/media/press-releases/15095/2025-12-21/fda-approves-genentechs-lunsumio-velo-fo