Roche’s subcutaneous lunsumio receives CHMP backing for R/R follicular lymphoma

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's subcutaneous (SC) formulation of Lunsumio for treating relapsed or refractory follicular lymphoma.

This SC injection offers a significantly reduced administration time compared to the intravenous (IV) infusion, with potentially high and long-lasting response rates, and would be the first fixed-duration, SC option for patients who have received at least two prior systemic therapies.

Lunsumio was the first-ever approved CD20xCD3 T-cell engaging bispecific antibody and has demonstrated high, durable response rates with a favorable safety profile in third-line or later follicular lymphoma. In clinical studies, approximately two-thirds of patients who achieved a complete response remained in remission after four years.

“If approved, the subcutaneous formulation could expand treatment options by offering people a fixed-duration therapy with a significantly faster administration time,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This innovation has the potential to improve the patient experience while maintaining the strong efficacy and safety profile already established with intravenous administration.”

The new formulation can be administered in about one minute, compared with the two to four hours typically required for IV infusion, while following the same dosing schedule. Lunsumio is designed as a fixed-duration therapy of approximately six to twelve months, depending on individual response, allowing patients a defined end date and the potential for treatment-free periods.

Submissions for approval of the subcutaneous formulation have also been made to other health authorities worldwide, including the U.S. Food and Drug Administration.

Lunsumio, alongside Columvi (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. By advancing innovative formulations and exploring new treatment combinations, Roche continues its commitment to broadening therapeutic options, enhancing patient convenience, and addressing diverse healthcare system needs.