- Roche Canada has received Health Canada authorization for Lunsumio (mosunetuzumab) in both intravenous (IV) and subcutaneous (SC) formulations for adults with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
- The approval provides patients and healthcare providers with flexible administration options, while maintaining a fixed-duration treatment regimen of 8 or 17 cycles.
- Lunsumio is a T-cell engaging bispecific antibody designed to deliver meaningful responses while offering planned periods off therapy, an important consideration for patients facing recurrent disease.
- The authorization was supported by data from the pivotal GO29781 study, which demonstrated clinically meaningful complete response rates, and Roche plans to work with provinces and territories to expand patient access across Canada.
Takeaways:
Roche’s dual-formulation (IV and SC) authorization for Lunsumio (mosunetuzumab) in Canada creates flexible, fixed-duration access for relapsed/refractory follicular lymphoma patients with at least two prior systemic therapies, offering planned periods off therapy. The bispecific T-cell engainer’s clinically meaningful complete response rates from the GO29781 study position it as a valuable option in a difficult-to-treat, relapsing disease setting.
Source: CA Newswire
