Genentech, part of the Roche Group, announced that the FDA has approved Lunsumio VELO™ (mosunetuzumab-axgb) as a subcutaneous (SC) injection for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more treatments. This approval is based on the results from the Phase I/II GO29781 study and is granted under accelerated approval. Full approval will depend on additional trials confirming the benefits.
Lunsumio VELO offers a faster administration time, taking about one minute for the injection, compared to 2-4 hours for the previous intravenous (IV) infusion. Like the IV version, it can be given on an outpatient basis and is a fixed-duration treatment, lasting as little as six months.
The approval is supported by results from the GO29781 study, showing that 75% of patients responded to the treatment, with 59% achieving a complete response. The median duration of response was 22.4 months. Common side effects include injection site reactions, fatigue, rash, and cytokine release syndrome (CRS), with 30% of patients experiencing CRS, though most cases were mild.
Lunsumio VELO is also being studied in ongoing Phase III trials for other forms of lymphoma. The European Commission has also approved Lunsumio SC for similar use in Europe.
Executive Statement
According to Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, 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.