Roche’s Lunsumio Gets Accelerated Approval for Later-Line Follicular Lymphoma

The FDA has granted accelerated approval to Roche’s Lunsumio (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or resistant follicular lymphoma (a common type of non-Hodgkin lymphoma) after two or more lines of systemic therapy.

Lunsumio is a bispecific antibody, administered intravenously, designed to activate a patient’s T-cells and redirect them to eliminate targeted B-cells that cause the disease.

The agency decision was based on the response rate in a phase 2 study. The treatment led to complete remission in 60 percent of patients and an objective response — a combination of complete and partial responses — in 80 percent. The median duration of response was 22.8 months.