By Fineline Cube 
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for a sub‑cutaneous (SC) formulation of Lunsumio (mosunetuzumab). The recommendation targets adult patients with relapsed or refractory follicular lymphoma (FL) who have failed two or more lines of systemic therapy. A final decision by the European Commission is expected shortly.
What Makes the SC Formulation a Game‑Changer?
- Rapid Administration – The SC injection takes roughly one minute, compared with the 2‑4‑hour infusion required for the IV formulation, without altering the dosing frequency.
- Fixed‑Duration Therapy – Lunsumio is designed as a 6‑12‑month course, offering patients a clear end date and the potential for a treatment‑free interval.
- Outpatient Convenience – The SC route allows treatment to be delivered in a clinic setting, reducing hospital stays and improving quality of life.
Lunsumio: A First‑In‑Class Bispecific Antibody
Lunsumio is a CD20×CD3 T‑cell‑engaging bispecific antibody that simultaneously binds CD20 on B cells and CD3 on T cells. This dual engagement redirects the patient’s own T cells to kill malignant B cells by releasing cytotoxic granules. The drug was approved in China in December 2024, and the SC formulation now expands its usability across Europe.
Regulatory and Market Implications
- CHMP Recommendation – The positive review signals strong regulatory momentum, likely accelerating full market approval and access across EU member states.
- Outpatient Oncology Shift – The SC format aligns with a broader industry trend toward ambulatory, patient‑centric care, potentially increasing adoption among oncologists and payers.
- Competitive Landscape – Lunsumio’s rapid, fixed‑duration therapy differentiates it from other CD20‑targeted agents that require continuous infusion or longer treatment courses.-Fineline Info & Tech