Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) has approved Lunsumio VELO™, a new subcutaneous formulation of Lunsumio, for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy. The approval marks an important update to Roche’s CD20xCD3 bispecific antibody therapy, offering a shorter administration time while maintaining the established efficacy and safety profile of intravenous Lunsumio.
Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, highlighted that follicular lymphoma is a lifelong condition for many patients, making reducing treatment burden a critical goal. He emphasized that the FDA approval of Lunsumio VELO enables administration in about one minute, substantially cutting clinic time and allowing care to better align with patients’ preferences and daily lives.
Lunsumio VELO
Lunsumio (mosunetuzumab) is a CD20xCD3 T-cell–engaging bispecific antibody developed by Roche. It works by simultaneously binding to CD20 expressed on malignant B cells and CD3 on T cells, redirecting the patient’s own immune system to recognize and eliminate cancer cells.
The VELO™ formulation allows subcutaneous administration, which leads to more gradual drug absorption compared with intravenous infusion. This approach is intended to maintain antitumor activity while potentially reducing infusion-related burden.
Clinical Trial Evidence Supporting Approval
The FDA approval is supported by results from subcutaneous mosunetuzumab cohorts within the ongoing GO29781 study (NCT02500407), which also includes earlier intravenous administration cohorts. These cohorts evaluated subcutaneous mosunetuzumab in adults with relapsed or refractory follicular lymphoma who had received at least three prior lines of therapy (3L+).
In this heavily pretreated population, treatment with Lunsumio VELO™ demonstrated robust antitumor activity. The objective response rate was 75%, with a complete response rate of 59%. Responses were durable, with a median duration of response of 22.4 months, supporting the clinical benefit of the subcutaneous formulation in advanced disease.
Administration and Safety Considerations
The safety profile of Lunsumio VELO™ was consistent with the known safety experience of mosunetuzumab. The most common adverse reactions reported in at least 20% of patients included injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain, and diarrhea.
CRS typically occurred during Cycle 1 and resolved after a median duration of two days. Although CRS can be severe and life-threatening, events in the study were manageable with established monitoring and treatment protocols.
Lunsumio VELO™ is administered subcutaneously using a step-up dosing schedule similar to the intravenous formulation. This schedule is designed to reduce the risk of cytokine release syndrome, particularly during early treatment cycles.
The subcutaneous option significantly shortens administration time compared with intravenous infusion, which may reduce treatment burden and improve the overall patient experience in outpatient oncology settings.
Dr. Ian Flinn, MD, PhD, of Tennessee Oncology and One Oncology, noted that the approval meaningfully expands access to effective therapy for people with follicular lymphoma. He underscored that the manageable cytokine release syndrome profile, combined with shorter administration time, makes Lunsumio VELO particularly well suited for delivery in community oncology practice settings.
Lunsumio VELO™ has been approved in the U.S. under the FDA’s accelerated approval pathway, with continued approval contingent on confirmation of clinical benefit in a dedicated confirmatory trial. In parallel, these data have been submitted to regulatory authorities worldwide, and the European Commission has already granted conditional marketing authorization for subcutaneous Lunsumio in adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Roche continues to expand the clinical program for Lunsumio VELO™, including the SUNMO study evaluating the regimen in combination with Polivy in second-line or later large B-cell lymphoma and the MorningLyte study assessing Lunsumio VELO with lenalidomide in previously untreated follicular lymphoma. Together, these efforts aim to further define the role of subcutaneous mosunetuzumab across disease settings and lines of therapy.
References
FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma, 22 December 2025, https://www.roche.com/media/releases/med-cor-2025-12-22
A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined with Atezolizumab in Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), ClinicalTrials.gov ID NCT02500407, https://clinicaltrials.gov/study/NCT02500407