The approval is based on the Phase I/II GO29781 clinical study, with full approval contingent upon further confirmatory trials.
Lunsumio VELO’s SC injection requires around one minute, compared to two-to-four hours for intravenous (IV) infusion. The regimen, a fixed-duration outpatient treatment, may be as short as six months.
The FDA decision is supported by the GO29781 study in patients with third-line or later FL. The study reported an objective response rate of 75% and a complete response rate of 59%. Median duration of response was 22.4 months.
Most common adverse reactions (≥20%) included injection site reactions, rash, fatigue, Covid-19 infection, cytokine release syndrome (CRS), diarrhoea, and musculoskeletal pain. The CRS rate was 30%, and events were mostly low grade, all resolving after a median of two days.
Genentech has submitted these data to global health authorities. The European Commission recently granted conditional marketing authorisation for Lunsumio SC in similar indications.
Roche global product development chief medical officer and head Levi Garraway said: “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance.
“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.”
In October 2025, Ventus Therapeutics entered a multi-year partnership with Genentech for the discovery and optimisation of new small-molecule medicines, utilising Ventus’ AI and machine learning-enabled ReSOLVE drug discovery platform.