European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
Rhea-AI Summary
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.
Positive
- 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
Negative
- Conditional authorisation rather than full approval
- Regulatory review outside EU still pending (FDA submitted)
- Phase III evidence for broader indications is ongoing
News Market Reaction
On the day this news was published, RHHBY declined 0.68%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- 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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