EU Grants Conditional Approval for Roche’s One-Minute Subcutaneous Lunsumio in Follicular Lymphoma

Roche announced that the European Commission has granted conditional marketing authorisation for a new subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) for adults with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The approval is supported by results from the Phase I/II GO29781 study, which demonstrated that the SC formulation achieved pharmacokinetic non-inferiority to intravenous (IV) administration and showed no unexpected safety issues.

The new SC version of Lunsumio can be administered in approximately one minute, offering a dramatic reduction in treatment time compared with the 2–4 hour IV infusion. This represents a significant shift in convenience for patients and may allow for broader outpatient initiation. Levi Garraway, Roche’s Chief Medical Officer, said the new formulation strengthens the treatment’s flexibility: “Lunsumio can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences.”

Lunsumio is a fixed-duration therapy and the first CD20xCD3 bispecific antibody approved for third-line or later FL. Both SC and IV formulations have shown high rates of deep and durable responses. In earlier data from the IV formulation, 57% of patients who achieved a complete response remained in remission at five years, underscoring the medicine’s long-term potential. Updated long-term results from both SC and IV arms of GO29781 will be presented at the upcoming 67th American Society of Hematology (ASH) Annual Meeting.

The newly approved SC formulation has already been submitted to several health authorities worldwide, including the U.S. Food and Drug Administration. Roche is also advancing multiple Phase III studies, such as the MorningLyte trial evaluating Lunsumio SC in combination with lenalidomide for previously untreated FL.

Lunsumio is part of Roche’s growing CD20xCD3 bispecific antibody portfolio, which also includes Columvi (glofitamab). The company continues to explore new combinations, formulations and earlier-line uses of these therapies across lymphoma types. By expanding administration options, Roche aims to improve patient convenience, streamline healthcare delivery, and widen access to innovative bispecific immunotherapies.