CHMP recommends EU approval of... Note

CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of a subcutaneous formulation of Lunsumio. This new formulation is for adult patients with relapsed or refractory follicular lymphoma after two or more prior systemic therapies. Lunsumio has demonstrated high and durable response rates, with a significant percentage of patients remaining in remission after four years. The subcutaneous administration offers a substantially reduced treatment time, taking only about one minute compared to lengthy intravenous infusions. If approved, this would be the first subcutaneous and fixed-duration treatment option for this patient group. Data from the Phase II GO29781 study supports this recommendation, showing pharmacokinetic non-inferiority and no new safety concerns. The rate and severity of cytokine release syndrome were low and manageable. Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that activates the patient's T cells to target and eliminate cancerous B cells. Roche is committed to expanding treatment options through innovative formulations and combinations. This subcutaneous version could improve the patient experience by offering a faster administration and a potential treatment-free period.