On February 22, Roche announced that the FDA has approved Lunsumio VELO™ ( motuzumab subcutaneous injection) , a CD20/CD3 bispecific antibody , for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in patients who have received at least two lines of systemic therapy .
Based on the results of the Phase I/II GO29781 study, motuzumab subcutaneous injection received accelerated approval from the FDA . Full approval may depend on validation and confirmation of efficacy in confirmatory trials. Previously, in November, this indication received conditional approval from the European Union.

Source: Roche official website
Compared to intravenous infusions that require 2-4 hours, the subcutaneous form of motuzumab can be administered in approximately 1 minute , significantly reducing treatment time. Like the intravenous version , the subcutaneous form can also be administered on an outpatient basis, with a fixed treatment duration, up to six months.
The FDA approval was based on the primary analysis results of the GO29781 study, which evaluated the efficacy of motuzumab subcutaneous formulation in patients with third-line or later-line follicular lymphoma. Results showed that patients treated with motuzumab subcutaneous formulation achieved an objective response rate (ORR) of 75% and a complete response rate (CR) of 59% , with a median duration of response of 22.4 months.
The most common adverse reactions include injection site reaction, fatigue, rash, cytokine release syndrome, COVID-19 infection, musculoskeletal pain, and diarrhea.
Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, stated that follicular lymphoma typically requires lifelong management, making it crucial to reduce the treatment burden on patients. This FDA approval allows for a treatment that can be completed in just one minute, significantly reducing patients' time spent in the clinic and helping to better align treatment options with their individual needs and preferences.

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