Roche(US:RHHBY) Globenewswire·2025-11-19 06:00Core Viewpoint - Roche has received conditional marketing authorization from the European Commission for Lunsumio® (mosunetuzumab) subcutaneous (SC) for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, based on the phase I/II GO29781 study results [1][2][6] Company Overview - Roche has been developing medicines for blood diseases for over 25 years and is committed to providing innovative treatment options across various hematologic diseases [10] - The company is investing significantly in research and development to enhance patient care and treatment experiences [10] Product Information - Lunsumio is a first-in-class CD20xCD3 bispecific antibody designed to engage T cells to eliminate B cells, with ongoing clinical trials for various B-cell non-Hodgkin lymphomas [9] - The SC formulation of Lunsumio allows for a one-minute injection, significantly reducing administration time compared to the 2-4 hour intravenous infusion [1][7] Clinical Study Results - The GO29781 study demonstrated pharmacokinetic non-inferiority of Lunsumio SC compared to IV administration, with an overall response rate (ORR) of 74.5% and a complete response (CR) rate of 58.5% in patients treated with the SC formulation [6] - The median duration of CR for patients receiving Lunsumio SC was 20.8 months, with common adverse events including injection-site reactions (60.6%) and fatigue (35.1%) [6] Market Context - Follicular lymphoma is the most common slow-growing form of non-Hodgkin lymphoma, with over 110,000 new diagnoses annually worldwide [8] - The approval of Lunsumio SC provides a new treatment option that aligns with patients' clinical needs and lifestyle preferences, addressing the challenges of treating relapsed FL [7][8]