Roche has received conditional marketing authorisation from the European Commission (EC) for Lunsumio (mosunetuzumab) subcutaneous (SC) for adults with relapsed or refractory follicular lymphoma (R/R FL) after at least two systemic therapies.
The approval follows positive results from the Phase I/II GO29781 study, which demonstrated that Lunsumio SC has pharmacokinetic non-inferiority to intravenous (IV) administration. No unexpected safety issues were observed.
The SC formulation facilitates outpatient initiation and decreases administration time to around one minute compared to the two-to-four-hour IV infusion process.
Lunsumio demonstrated a high deep and durable remissions rate and a favourable benefit-risk profile in third-line or later FL with both IV and SC routes.
The IV formulation was the initial bispecific antibody approved for this indication, with 57% of patients achieving a complete remission (CR) which was sustained over five years.
Roche chief medical officer and global product development head Levi Garraway stated: “Building on the benefits of its fixed-duration dosing schedule, 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.
“Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.”
The company has submitted these outcomes to other healthcare authorities globally, including the US Food and Drug Administration.
Phase III trials of Lunsumio SC are underway, including the MorningLyte study investigating the therapy combined with lenalidomide in previously untreated FL patients.
Lunsumio is part of Roche’s cluster of differentiation (CD)20xCD3 bispecific antibody portfolio, alongside Columvi (glofitamab).
In October 2025, the FDA had granted approval for Roche’s Gazyva/ Gazyvaro (obinutuzumab) to treat adult patients with active lupus nephritis (LN) who were on standard therapy.
