Posted by Michael Wonder on 22 Dec 2025
FDA approves Roche’s Lunsumio Velo for subcutaneous use in relapsed or refractory follicular lymphoma
22 December 2025 - Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse.
Roche announced today that the US FDA has approved CD20xCD3 bispecific Lunsumio Velo (mosunetuzumab), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study.
