Roche | MEDIA
Follow
European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
The European Commission has granted conditional marketing authorization for Lunsumio subcutaneous (SC) for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. This approval stems from the GO29781 study, which demonstrated pharmacokinetic non-inferiority of Lunsumio SC compared to its intravenous form. Lunsumio SC offers a significantly reduced administration time of approximately one minute, enhancing patient convenience and lifestyle flexibility. It provides a fixed-duration treatment option that can be initiated in an outpatient setting. The drug has shown a favorable benefit-risk profile with high rates of deep and durable remissions in third-line or later follicular lymphoma. Long-term data for both IV and SC administration routes will be presented at the upcoming ASH Annual Meeting. Phase III studies, including one investigating Lunsumio SC in combination with lenalidomide, are ongoing. Lunsumio is part of Roche's bispecific antibody portfolio, aimed at improving patient experience and offering treatment choices. Follicular lymphoma is the most common indolent form of non-Hodgkin lymphoma, often characterized by relapse. Lunsumio's mechanism involves T-cell engagement to eliminate B cells.