CHMP recommends approval of Lunsumio for follicular lymphoma.- Roche
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Lunsumio (mosunetuzumab) from Roche, intended for the treatment of relapsed or refractory follicular lymphoma.
Lunsumio was reviewed under EMA’s accelerated assessment programme.
Lunsumio will be available as 1 mg and 30 mg concentrate for solution for infusion. The active substance of Lunsumio is mosunetuzumab, a bispecific monoclonal antibody which simultaneously binds to CD20 on B cells and CD3 on T cells, thereby inducing the death of malignant B cells. The benefits of Lunsumio are the high proportion of patients with a complete response and the durability of the treatment response. The most common side effects are cytokine release syndrome, neutropenia, pyrexia, hypophosphataemia and headache.
The full indication is: Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
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