Global pharma powerhouse Roche has announced that the US FDA has approved its CD20xCD3 bispecific therapy, Lunsumio VELO (mosunetuzumab), in a subcutaneous (SC) formulation for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic treatments. 

 

The approval, granted under accelerated status, is based on results from the phase I/II GO29781 study. Full approval will depend on verification of clinical benefit in a confirmatory trial.

 

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

 

Lunsumio VELO dramatically cuts treatment time, requiring a roughly one-minute injection compared with traditional 2–4 hour intravenous (IV) infusions. Like its IV counterpart, Lunsumio VELO is a fixed-duration outpatient therapy, potentially completed in as little as six months, rather than continuing indefinitely until disease progression.

 

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr Ian Flinn, 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.”

 

The FDA decision follows the primary analysis of GO29781, which evaluated Lunsumio VELO in third-line or later FL patients. 

 

The study showed an objective response rate of 75% (95% CI: 64–83%) and a complete response rate of 59% (95% CI: 48–69%), with a median duration of response of 22.4 months. The most common side effects (≥20%) included injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients, was mostly low-grade, and resolved within a median of two days.

 

Roche has also submitted these data globally, and the European Commission recently granted conditional marketing authorization for Lunsumio SC in similar patient populations.