Health Canada has granted market authorizations for Hoffmann-La Roche Limited’s 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 decision covers both intravenous (IV) and subcutaneous (SC) formulations, giving clinicians and patients flexible administration options across care settings. Roche Canada said the dual authorization underscores its commitment to delivering innovative solutions that respond to the needs of patients and the Canadian healthcare system.
Follicular lymphoma is a common, slow-growing form of non-Hodgkin lymphoma that often returns after initial treatment, with successive lines of therapy typically becoming less effective over time. In Canada, an estimated 12,000 people were diagnosed with non-Hodgkin lymphoma in 2025, highlighting the ongoing need for additional options for relapsed disease. Patient advocates noted that for Canadians living with follicular lymphoma, the disease course is often marked by repeated relapses, making new therapies for later lines of treatment particularly important. The Lunsumio authorization is being viewed as a meaningful step forward for individuals who have already cycled through multiple systemic regimens.
Lunsumio is a T‑cell–engaging bispecific antibody administered for a fixed duration of 8 or 17 treatment cycles, designed to offer a predictable schedule that includes planned periods off therapy. Treating hematologists highlighted that the availability of both IV and SC formulations can help balance clinical goals with patients’ personal lives, potentially reducing time spent in healthcare settings and allowing care teams to better tailor the treatment experience. The Health Canada decision is supported by data from the pivotal GO29781 study, which showed a clinically meaningful effect on complete response rates in the indicated population.
Roche Canada said it is now working with provincial and territorial authorities to secure access to both Lunsumio IV and Lunsumio SC for eligible patients across the country as quickly as possible. The company emphasized that faster, more flexible administration options could support diverse patient needs in community and academic centers nationwide.
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