Glofitamab

Roche has scored an FDA approval for Lunsumio Velo as a subcutaneous formulation for the third-line treatment of follicular lymphoma. Three years after its initial FDA approval, Roche has made up for an early disadvantage with its blood cancer drug Lunsumio amid competition among CD20xCD3 bispecific antibodies.The FDA has approved Lunsumio Velo as a subcutaneous formulation for the treatment of follicular lymphoma after two or more lines of systemic therapy, Roche’s Genentech unit said Monday.Lunsumio was the first anti-CD20 bispecific approved by the FDA with a go-ahead in December 2022 to treat third-line follicular lymphoma. As an off-the-shelf intravenous infusion, Lunsumio boasts a convenience edge over individualized CAR-T therapies.But that advantage was soon lost to AbbVie and Genmab’s rival T-cell engager Epkinly, which started off as a subcutaneous injection with an initial nod in third-line diffuse large B-cell lymphoma (DLBCL), followed by a June 2024 green light to enter follicular lymphoma.Now, Lunsumio Velo is allowing Roche to fill that gap of administration convenience; all the while, the company has been touting its fixed-duration regimen, which allows patients to stop treatment after a few cycles; Epkinly is given indefinitely until disease progression or unacceptable toxicity.The new under-the-skin formulation reduces the Lunsumio administration time to about one minute compared with two to four hours for an infusion, depending on the treatment cycle, according to Roche.“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” Roche’s head of global product development and chief medical officer, Levi Garraway, M.D., Ph.D., said in a Dec. 22 statement. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.” The latest approval is based on data from the phase 1/2 GO29781 trial, which showed the two formulations lead to similar concentrations in the blood. Lunsumio Velo also demonstrated an objective response rate of 75% and a complete response rate of 59%. The median duration of response was 22.4 months.As Lunsumio’s original nod is still an accelerated approval, so is the current nod for the subcutaneous version. Roche is testing the drug alongside lenalidomide (Bristol Myers Squibb’s Revlimid) in the phase 3 MorningLyte study in previously untreated follicular lymphoma.Making intravenous infusions into subcutaneous injections has become a popular strategy among drugmakers. Roche itself got FDA approvals last year for subcutaneous versions of its PD-L1 cancer drug Tecentriq and popular multiple sclerosis treatment Ocrevus. More recently, Merck & Co.’s subcutaneous Keytruda and Johnson & Johnson’s EGFR lung cancer med Rybrevant Faspro also gained the FDA’s blessing.Drugmakers should break from the habit of going to intravenous first and start thinking about subcutaneous development from the get-go, Helen Torley, CEO of the drug delivery specialist Halozyme, said at the Fierce Biotech Week 2025 conference in October.To do that, drug developers need to get familiar with the early pharmacokinetic profile of subcutaneous drugs and build an understanding of how that can be translated into the kind of data needed to pick the dose in later-stage clinical trials, Torley said. At least Roche has already been using the subcutaneous version in other Lunsumio studies, including MorningLyte and Sunmo, which recently reported that Lunsumio’s combination with Roche’s Polivy significantly reduced the risk of progression or death by 59% versus the traditional R-GemOx regimen in second-line LBCL patients who are not eligible for transplant. Roche’s other CD20xCD3 drug, Columvi, recently hit a setback, as the FDA declined to approve it in combination with chemotherapy for the treatment of second-line, transplant-ineligible DLBCL because of unconvincing data in U.S. patients.

Lunsumio VELO reduces administration time from 2-4 hours to approximately one minuteAvailability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse1,2 Basel, 22 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the phase I/II GO29781 study.1 Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial. “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.” Lunsumio VELO reduces treatment administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated. “This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr Ian Flinn, MD, PhD, Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.” The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively.1 The median duration of response was 22.4 months (95% CI: 16.8–22.8).1 The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhoea.1 The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15).1 CRS can be severe and life-threatening. Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorisation of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. Roche continues to advance its bispecific antibody programme in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL. About the GO29781 study The GO29781 [NCT02500407] study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO™ (mosunetuzumab) was established on the basis of objective response rate and duration of response. About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.3,4 The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis.2 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.4,5 About Lunsumio VELO™ (mosunetuzumab)Lunsumio VELO is a subcutaneous formulation of mosunetuzumab, a 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. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications. About Roche in haematologyRoche 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 administered intravenously), Lunsumio SC/VELO™ (mosunetuzumab administered subcutaneously) 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 the 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. All trademarks used or mentioned in this release are protected by law. References[1] Roche data on file. [2] Fowler NH, at al. Moving T-Cell Therapies into the Standard of Care for Patients with Relapsed or Refractory Follicular Lymphoma: A Review. Targ Oncol. 2024;19:495–510.[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited December 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.[4] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited December 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.[5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. 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