Roche announces EC granted conditional marketing approval of Lunsumio SC

Roche (RHHBY) announced that the European Commission, EC, has granted conditional marketing authorisation of Lunsumio subcutaneous, SC, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Approval is based on results from the phase I/II GO29781 study, which showed that Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous administration, with no unexpected safety signals. Lunsumio has shown a favourable benefit-risk profile and high rates of deep and durable remissions with both IV and SC administration routes in third-line or later FL.1,4 Lunsumio IV was the first bispecific antibody approved for 3L+ FL and has shown sustained responses, with 57% of patients who achieved a CR still in remission at five years. Long-term data from the SC and IV arms of the GO29781 study will be presented at the 67th American Society of Hematology Annual Meeting and Exposition.