Health Canada has granted market authorization 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 announcement was made by Hoffmann-La Roche Limited (Roche Canada) on June 8, 2026.
Flexible Administration Options
The authorizations include both intravenous (IV) and subcutaneous (SC) formulations, providing healthcare providers and patients with flexible administration options. This dual approval allows for tailored treatment approaches based on individual patient needs and clinical settings.
Clinical Significance
Follicular lymphoma is a common, slow-growing form of non-Hodgkin lymphoma (NHL) that often returns after initial treatments. It is estimated that in 2025, 12,000 Canadians were diagnosed with NHL. 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.
"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.
Patient and Physician Perspectives
"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 of 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."
Basis of Authorization
The Health Canada authorization is based on results from the pivotal study GO29781, which demonstrated clinically meaningful treatment effect on complete response. The study showed that Lunsumio induced durable responses in patients with relapsed or refractory FL who had limited treatment options.
Next Steps
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. The company aims to collaborate with healthcare systems to facilitate timely access to this new treatment option.
