Roche has announced FDA’s approval of Lunsumio VELO (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) following two or more lines of systemic therapy.¹

Based on results collected during the Phase I/II GO29781 study, Lunsumio VELO was granted accelerated approval, with full approval remaining contingent on the verification and confirmation of benefit in a confirmatory trial.¹

The GO29781 study is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy, and pharmacokinetics of Lunsumio VELO administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma.¹ It’s efficiency was established on the basis of objective response rate and duration of response.

Lunsumio VELO is a SCformulation of mosunetuzumab, a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells, activating and redirecting a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells.¹

Lunsumio VELO is designed to reduce treatment administration time with an estimated injection time of one minute, compared to a 2-4 hour IV infusion, Similar to Lunsumio administered intravenously, Lunsumio VELO holds the ability to be administered in outpatient, and is a fixed-duration treatment recommended for defined periods with lengthens as short as six months.¹ By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

What is Lunsumio VELO’s approval based on?

FDA’s approval is based on and supported by the primary analysis of the GO29781 study evaluating Lunsumio VELO in patients with third-line or later FL. Study results demonstrated the objective response rate (ORR) and complete response rate (CRR) in patients treated with Lunsumio VELO, with ORR reaching 75% and CRR reaching 59%, respectively.¹

The median duration of response was 22.4 months, with the most common adverse reactions including the following:

• Injection site reactions
• Fatigue, rash
• Cytokine release syndrome
• COVID-19 infection
• Musculoskeletal pain
• Diarrhea

Reported events were mostly lower grade and all were resolved after a median duration of two days, and long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition.¹

Roche is expected to continue advancing its bispecific antibody programs in lymphoma, with ongoing Phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment.¹

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Ian Flinn, MD, PhD, with Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

Sources

1. FDA approves Roche’s Lunsumio VELO for subcutaneous use in relapsed or refractory follicular lymphoma Roche. December 21, 2025 https://www.roche.com/investors/updates/inv-update-2025-12-22