Mosunetuzumab receives FDA approval for the treatment of R/R follicular lymphoma

On December 22, 2022, it was announced that mosunetuzumab-axgb, a CD20 × CD3 T cell-engaging bispecific antibody, had received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior lines of systemic therapy. This approval marks a major milestone for this patient group, who have previously had limited treatment options.¹

The approval is based on key results from the phase II GO29781 study (NCT02500407), previously reported on the Lymphoma Hub, in which mosunetuzumab demonstrated high and durable response rates in heavily pretreated patients with R/R FL, including patients at high risk of progression and those refractory to previous treatment. Latest results from the study demonstrated overall and complete response rates of 80% and 60%, respectively. Responses were maintained for ≥18 months in 57% of patients. The most common adverse event was cytokine release syndrome, which was observed in 39% of patients for a median duration of 3 days.¹

This approval follows the European Commission (EC) approval in June 2022, previously reported on the Lymphoma Hub.