The US Food and Drug Administration (FDA) approved mosunetuzumab (Lunsumio VELO), a CD20xCD3 bispecific antibody, as a subcutaneous formulation for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Mosunetuzumab reduces administration time to approximately one minute from 2-4 hours for intravenous infusion, according to Genentech, the therapy’s manufacturer. It is a fixed-duration treatment, typically as short as six months, and can be administered in an outpatient setting.
The approval is based on the phase I/II GO29781 study, which showed a 75% objective response rate and a 59% complete response rate in patients with third-line or later disease. While cytokine release syndrome was observed in 30% of patients, the majority of events were low-grade and resolved within two days, enabling the use of this bispecific antibody in community practice settings according to a press release by Genentech.
“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Ian Flinn, MD, PhD, of Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”
