Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its drug Columvi (glofitamab). Roche is seeking FDA approval for the use of Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. A decision on the application is expected by July 20, 2025.
Columvi’s Mechanism of Action and Potential Impact
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Its novel 2:1 structural format allows for a higher binding affinity with CD20 on the surface of B cells compared to traditional 1:1 bispecific antibodies, inducing rapid T cell activation, cytokine release, and leading to target cell lysis.
Phase III STARGLO Study Results and Ongoing Trials
Roche’s filing leverages results from the Phase III STARGLO study, which demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) when glofitamab was combined with GemOx compared to rituximab combined with GemOx. Previously approved in the US for the treatment of R/R DLBCL after second-line or above systemic treatment, Columvi is also subject to the ongoing Phase III SKYGLO study, which is investigating the combination of glofitamab with Polivy (polatuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin, and prednisone (R-CHP) in previously untreated DLBCL patients.-Fineline Info & Tech
