Roche Bags EU Nod for SC Formulation of Lunsumio, Re-Igniting Bispecific Battle with Tepkinly
The European Commission granted conditional marketing authorisation to Roche's subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory follicular lymphoma after two or more systemic therapies on 19 November 2025.
The SC formulation offers a one-minute administration compared to the previous 2–4 hour IV infusion, improving patient convenience.
Approval was based on the phase I/II GO29781 study, which demonstrated pharmacokinetic non-inferiority and no unexpected safety signals for the SC versus IV formulation.
Lunsumio is a first-in-class CD20xCD3 bispecific antibody, and its approval re-ignites competition in the bispecific antibody market with AbbVie/Genmab's Tepkinly (epcoritamab).
Roche is continuing to develop Lunsumio in combination with other therapies and in different disease settings, including ongoing phase III trials.