Roche has announced that the European Commission has granted conditional marketing authorisation for the subcutaneous (SC) formulation of Lunsumio® (mosunetuzumab) for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. The approval is supported by data from the phase I/II GO29781 study, which demonstrated pharmacokinetic non-inferiority of the SC formulation compared to intravenous (IV) administration, with no unexpected safety concerns.
The new SC formulation allows Lunsumio to be delivered as a rapid, one-minute injection, significantly reducing treatment time compared with the traditional 2–4 hour IV infusion. As a fixed-duration treatment that can be started in an outpatient setting, it offers greater convenience and flexibility for patients with advanced follicular lymphoma.
Both SC and IV routes of Lunsumio have shown a favourable benefit-risk profile and high rates of deep, durable remissions in third-line or later FL. Lunsumio IV was the first bispecific antibody approved for this setting and has demonstrated sustained responses, with a majority of patients who achieved complete remission remaining in remission at five years. Updated long-term data from both formulations will be presented at the upcoming 67th American Society of Hematology (ASH) Annual Meeting.
Regulatory submissions for Lunsumio SC are also underway in other countries, including with the US FDA. Meanwhile, phase III studies—such as the MorningLyte trial evaluating Lunsumio SC combined with lenalidomide in previously untreated FL—are ongoing. Together with Columvi® (glofitamab), Lunsumio forms a key part of Roche’s CD20xCD3 bispecific antibody portfolio, aimed at expanding treatment options and improving patient experience across lymphoma care.
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