The U.S. Food and Drug Administration Approves Mosunetuzumab-axgb (Lunsumio) for Follicular Lymphoma

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On December 22, 2022, the U.S. Food and Drug Administration (FDA) announced it has approved the use of mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific antibody, for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Bispecific antibodies are engineered hybrid molecules with two unique binding domains, each of which recognizes a certain target, unlike monoclonal antibodies that have two arms that both recognize the same target antigen. This approval marks the first bispecific antibody approved to treat FL.

“This approval marks a monumental moment for the treatment of patients with relapsed/refractory follicular lymphoma,” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “We commend those who contribute to accelerating research for the benefit of patients and ensuring a brighter future for those touched by this disease.”

For more information on the FDA approval of mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), visit the FDA’s website.  To learn more about treatment options for FL, visit the FL learning center.