Roche (RHHBY, Financial) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for glofitamab. This application seeks approval for its use in combination with gemcitabine and oxaliplatin (GemOx regimen) to treat relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) patients who have undergone at least one prior treatment and are ineligible for autologous stem cell transplant.
The FDA decision is expected by July 2025. The application is based on the Phase III STARGLO study, showing a statistically and clinically significant improvement in overall survival with glofitamab plus GemOx compared to rituximab plus GemOx. Glofitamab is a bispecific antibody targeting CD3 on T cells and CD20 on B cells, enhancing T-cell mediated cytotoxicity against B cells.
