EU Grants Conditional Marketing Authorization to Roche’s Lunsumio for Follicular Lymphoma

The European Commission has granted Roche’s Lunsumio (mosunetuzumab) conditional marketing authorization for the treatment of adult patients with relapsed or refractory follicular lymphoma who received at least two prior systemic therapies.

Lunsumio, a T-cell engaging bispecific antibody, is the first bispecific antibody approved in Europe for patients with relapsed/refractory follicular lymphoma.

The treatment demonstrated a high complete response rate in a phase 1/2 study.  The conditional marketing authorization, which requires less comprehensive data than usual, was because the drug addresses an unmet medical need.