European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
Roche (OTCQX: RHHBY) announced the European Commission granted conditional marketing authorisation for Lunsumio (mosunetuzumab) subcutaneous for adult patients with relapsed or refractory follicular lymphoma after two or more systemic therapies (3L+ FL) on 19 November 2025.
Approval is based on the phase I/II GO29781 study showing pharmacokinetic non‑inferiority vs IV and no unexpected safety signals. Lunsumio SC offers an approximately one‑minute injection versus a 2–4 hour IV infusion. Long‑term IV data show 57% of patients in CR remained in remission at five years. Data will be presented at ASH and have been submitted to other regulators including the FDA; Phase III studies including MorningLyte are ongoing.
Roche (OTCQX: RHHBY) ha annunciato che la Commissione Europea ha concesso autorizzazione all'immissione in commercio condizionale per Lunsumio (mosunetuzumab) sottocute per adulti affetti da linfoma follicolare recidivante o refrattario dopo due o più terapie sistemiche (3L+ FL) il 19 novembre 2025.
L'approvazione si basa sullo studio di fase I/II GO29781 che mostra non inferiorità farmacocinetica vs IV e nessun segnale di sicurezza imprevedibile. Lunsumio SC offre un'iniezione di circa un minuto rispetto a una somministrazione endovenosa IV di 2–4 ore. I dati a lungo termine IV mostrano il 57% dei pazienti in CR è rimasto in remissione per cinque anni. I dati saranno presentati all'ASH e sono stati sottoposti ad altri regolatori, tra cui la FDA; gli studi di fase III, tra cui MorningLyte, sono in corso.
Roche (OTCQX: RHHBY) anunció que la Comisión Europea concedió autorización de comercialización condicionada para Lunsumio (mosunetuzumab) subcutánea para pacientes adultos con linfoma folicular recidivado o refractario tras dos o más terapias sistémicas (3L+ FL) el 19 de noviembre de 2025.
La aprobación se basa en el estudio de fase I/II GO29781 que muestra no inferioridad farmacocinética frente a IV y no se han observado señales de seguridad inesperadas. Lunsumio SC ofrece una inyección de aproximadamente un minuto frente a una infusión IV de 2–4 horas. Los datos a largo plazo IV muestran el 57% de los pacientes en CR permanecieron en remisión durante cinco años. Los datos serán presentados en ASH y han sido enviados a otros reguladores, incluida la FDA; los ensayos de fase III, incluyendo MorningLyte, están en curso.
로체(Roche) (OTCQX: RHHBY)는 유럽연합 집행위원회가 성인 재발성 또는 불응성 여포성 림프종에 대해 두 번 이상의 전신 치료 후에 조건부 시판허가를 Lunsumio(mosunetuzumab) 피하주사로 부여했다고 2025년 11월 19일 발표했다.
승인은 1상/2상 GO29781 연구에 기초하며 경구투여 대비 정맥주사 대비 약동학적 비열등성 및 예기치 않은 안전신호가 없음을 보여준다. Lunsumio SC는 약 1분의 주사로 제공되며 2-4시간의 IV 주입과 비교된다. 장기간 IV 데이터는 CR 환자의 57%가 5년간 관해를 유지한다는 것을 보여준다. 데이터는 ASH에서 발표될 예정이며 FDA를 포함한 다른 규제당국에 제출되었고 MorningLyte를 포함한 3상 연구가 진행 중이다.
Roche (OTCQX: RHHBY) a annoncé que la Commission européenne a accordé une autorisation de mise sur le marché conditionnelle pour Lunsumio (mosunetuzumab) sous-cutanée chez les patients adultes atteints de lymphome folliculaire relapsé ou réfractaire après deux thérapies systémiques ou plus (3L+ FL) le 19 novembre 2025.
L'approbation repose sur l'étude de phase I/II GO29781 montrant une non-infériorité pharmacoclinique vis-à-vis de l'IV et l'absence de signaux de sécurité inattendus. Lunsumio SC offre une injection d'environ une minute contre une perfusion IV de 2 à 4 heures. Les données à long terme IV montrent que 57% des patients en CR sont restés en rémission au bout de cinq ans. Les données seront présentées à l'ASH et ont été soumises à d'autres régulateurs, dont la FDA; des essais de phase III, incluant MorningLyte, sont en cours.
Roche (OTCQX: RHHBY) gab bekannt, dass die Europäische Kommission eine bedingte Zulassung für Lunsumio (mosunetuzumab) subkutan bei erwachsenen Patienten mit rezidivierendem oder refraktärem follikulärem Lymphom nach zwei oder mehr systemischen Therapien (3L+ FL) am 19. November 2025 erteilt hat.
Die Zulassung basiert auf der Phase I/II-Studie GO29781, die pharmakokinetische Nicht-Unterlegenheit gegenüber IV zeigt und keinerlei unerwartete Sicherheits_signale aufweist. Lunsumio SC bietet eine ungefähr eine Minute lange Injektion im Vergleich zu einer 2–4-stündigen IV-Infusion. Langfristige IV-Daten zeigen, dass 57% der Patienten in CR auch nach fünf Jahren in Remission blieben. Die Daten werden auf der ASH vorgestellt und wurden auch anderen Regulierungsbehörden, einschließlich der FDA, vorgelegt; Phase-III-Studien, einschließlich MorningLyte, befinden sich in laufender Durchführung.
روش (OTCQX: RHHBY) أعلنت أن المفوضية الأوروبية منحت ترخيصاً تسويقياً مشروطاً لـ Lunsumio (mosunetuzumab) تحت الجلد للبالغين المصابين باللمفومة الشعاعية المتكررة أو المقاومة بعد علاجات منهجية اثنين أو أكثر (3L+ FL) في 19 نوفمبر 2025.
تعتمد الموافقة على دراسة المرحلة I/II GO29781 التي تُظهر لا تفوق دوائي حيوي مقارنة بال IV ولا إشارات سلامة غير متوقعة. يقدم Lunsumio SC حقنة تستغرق حوالي دقيقة واحدة مقابل تسريب IV لمدة 2–4 ساعات. تُظهر بيانات IV طويلة الأجل أن 57% من المرضى في CR ظلوا في حالة من التحسن لمدة خمس سنوات. ستُعرض البيانات في ASH وقد تم تقديمها إلى منظمات تنظيمية أخرى بما في ذلك FDA؛ دراسات المرحلة III بما فيها MorningLyte جارية.
- European Commission granted conditional marketing authorisation
- Lunsumio SC delivers an ≈1‑minute administration vs 2–4 hour IV infusion
- GO29781 showed PK non‑inferiority of SC versus IV with no unexpected safety signals
- 57% of CR patients on Lunsumio IV remained in remission at five years
- Conditional authorisation rather than full approval
- Regulatory review outside EU still pending (FDA submitted)
- Phase III evidence for broader indications is ongoing
- Lunsumio provides high rates of deep and long-lasting responses in third-line and later follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses1,2
- Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately one minute
- Availability of Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences
Basel, 19 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional marketing authorisation of Lunsumio® (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) 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 (IV) administration, with no unexpected safety signals.3
“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.”
Lunsumio SC is a fixed-duration treatment that can be initiated in the outpatient setting and has the potential to substantially reduce treatment administration time with an approximately one-minute injection, compared with a 2-4 hour IV infusion.
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 (3L+) FL.1,4 Lunsumio IV was the first bispecific antibody approved for 3L+ FL and has shown sustained responses, with
These data have been submitted to other healthcare authorities around the world, including the US Food and Drug Administration.
Phase III studies involving Lunsumio SC are ongoing, including the MorningLyte trial investigating Lunsumio SC in combination with lenalidomide in previously untreated FL. Lunsumio, along with Columvi® (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Roche’s commitment to improve the patient experience and provide more choice to suit diverse patient and healthcare system needs.
About the GO29781 study
The GO29781 study is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab), administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary objective for the SC cohort was to show pharmacokinetic (PK) non-inferiority of the SC formulation of Lunsumio compared with the IV formulation, based on the study’s co-primary endpoints. Key secondary endpoints include complete response (CR) rate, objective response rate (ORR), duration of response, progression-free survival, safety and tolerability.
This approval is based on a primary analysis that explored Lunsumio administered subcutaneously in patients with 3L+ follicular lymphoma. Results from the primary analysis showed PK non-inferiority compared with IV administration, and the ORR and CR rates in patients treated with the fixed-duration, subcutaneous formulation of Lunsumio were
About follicular lymphoma
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.2,5 It typically responds well to treatment but is often characterised by periods of remission and relapse.2 The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.5 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.5,6
About Lunsumio® (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, other blood cancers and autoimmune disorders.
About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] Budde E, et al. Fixed treatment duration mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies: 5-year follow-up of a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5352.
[2] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited November 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.
[3] Roche data on file.
[4] Assouline S, et al. Fixed-duration subcutaneous mosunetuzumab continues to demonstrate high rates of durable responses in patients with relapsed/refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5353.
[5] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited November 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[6] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited November2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.
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