Health Canada authorizes Lunsumio® (mosunetuzumab) for the treatment of relapsed or refractory follicular lymphoma after two or more systemic therapies

MISSISSAUGA, ON, June 8, 2026 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorizations for Lunsumio (mosunetuzumab for injection) and Lunsumio SC (mosunetuzumab injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grades 1 – 3a) who have received at least two prior systemic therapies. The authorizations include both intravenous (IV) and subcutaneous (SC) formulations, providing healthcare providers and patients with flexible administration options.¹

"The authorization of both IV and SC formulations of Lunsumio reflects Roche's commitment to providing innovative solutions that address the evolving needs of patients, and the Canadian healthcare systems alike," said Dan Edgcumbe, Vice President Medical & Regulatory Affairs and Country Medical Director, Roche Canada Pharma.

Follicular lymphoma is a common, slow-growing form of non-Hodgkin lymphoma (NHL) that often returns after initial treatments.^2,3 It is estimated that in 2025, 12,000 Canadians were diagnosed with NHL.⁴ While many patients respond to early lines of therapy, the disease is characterized by cycles of remission and relapse, with each subsequent treatment often becoming less effective.⁵

"For Canadians living with follicular lymphoma, the journey is often marked by the uncertainty of relapse. Each time the disease returns, the need for additional treatment options becomes more urgent," said Antonella Rizza, CEO, Lymphoma Canada. "This authorization is a significant step forward, offering a new sense of hope for patients who continue their treatment journey after previous therapies."

Lunsumio is a T-cell engaging bispecific antibody administered for a fixed duration of 8 or 17 cycles. This regimen provides a predictable treatment schedule for patients with FL, including planned periods off therapy.

"In the management of follicular lymphoma, providing patients with options that balance clinical goals with their personal lives is essential. The introduction of new therapies that offer faster, more flexible administration is a meaningful advancement," said Dr Sarit Assouline, Chief of the Division of Hematology and Senior Investigator at the Jewish General Hospital Montreal. "This flexibility allows us to better tailor the treatment experience to the individual, potentially reducing the time spent in a healthcare setting and supporting the diverse needs of patients across Canada."

The Health Canada authorization is based on results from the pivotal study GO29781, which demonstrated clinically meaningful treatment effect on complete response.¹

Roche Canada is now committed to working with provincial and territorial jurisdictions to ensure that both the IV and SC formulations are accessible to patients across Canada as quickly as possible.

About the Health Canada Authorization¹
The approval of Lunsumio and Lunsumio SC was supported by data from the GO29781 study, which evaluated the efficacy and safety of mosunetuzumab. The trial demonstrated that Lunsumio could induce durable remissions in patients who had progressed after multiple previous lines of therapy. The subcutaneous formulation (Lunsumio SC) was specifically designed to provide a more efficient administration route, with a small injection volume (1 mL or less) delivered in minutes, compared to the several hours required for traditional intravenous infusion.

About Lunsumio (mosunetuzumab)¹
Lunsumio is a bispecific antibody that targets CD20 on the surface of B-cells and CD3 on the surface of T-cells. Lunsumio attaches to the B cells, including cancerous B cells, and T cells, acting as a bridge between the two cells. This activates the T cells, which can cause them to multiply and kill the B cells.

About Follicular Lymphoma²
Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma. Although it is often responsive to chemotherapy and immunotherapy initially, it is considered incurable, and most patients will experience relapse. For patients who have failed two or more prior therapies, treatment options have historically been limited.

About Roche in Hematology
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.

About Roche Canada
At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.

With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone.

And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.

Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs around 2,000 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics division in Laval, Québec.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.

References
[1] Lunsumio Product Monograph, April 10, 2026.

[2] Canadian Cancer Society. Follicular Lymphoma. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/treatment/treatment-by-type/follicular-lymphoma. Accessed on April 23, 2026.

[3] Lymphoma Canada. Follicular Lymphoma Fact Sheet. Available at https://www.lymphoma.ca/wp-content/uploads/2021/08/LymphomaCanada_FactSheet_FL_Digital.pdf. Accessed on April 23, 2026.

[4] Canadian Cancer Society. Non-Hodgkin Lymphoma Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed on April 23, 2026.

[4] Canadian Cancer Society. Non-Hodgkin Lymphoma Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed on April 23, 2026.

[5] National Library of Medicine. Clinical outcomes in patients relapsed/refractory after ≥2 prior lines of therapy for follicular lymphoma. Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC9869623/. Accessed on April 23, 2026.

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SOURCE Hoffmann-La Roche Limited (Roche Canada)

Seraphina Opel, Communications Manager, Hoffmann-La Roche Limited (Roche Canada), Phone: [phone], Email: [email protected]