The FDA has approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a novel bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL).
The indication covers R/R FL patients who have received at least two prior systemic therapies.
Patients with the cancer subtype have had limited treatment options and significant morbidity and mortality.
The approval of Lunsumio is the first time the FDA has approved a bispecific antibody to treat one of the most common slow-growing forms of non-Hodgkin’s lymphoma.
Lunsumio is a CD20xCD3 T-cell-engaging bispecific antibody.Priority review and breakthrough therapy designation
FDA granted priority review to Lunsumio this summer. The agency granted it breakthrough therapy designation (BTD) in 2020.
In the pivotal Phase 2 GO29781 study, 60% (54/90) of Lunsumio recipients who received at least two prior therapies had complete remission. A total of 80% (72/90) of patients had …