Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Columvi (glofitamab-gxbm). This application seeks approval for Columvi to be used in conjunction with gemcitabine and oxaliplatin (GemOx) for treating individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have undergone at least one previous treatment regimen and are unsuitable candidates for autologous stem cell transplant. The FDA is anticipated to issue its decision regarding this application by July 20, 2025.
The submission for FDA approval is supported by results from the Phase III STARGLO study, in which the combination of Columvi and chemotherapy demonstrated a statistically significant and clinically meaningful enhancement in overall survival rates.
