Glofitamab (Columvi)

Mechanism of action

From the NCI Drug Dictionary: A bispecific monoclonal antibody, with potential antineoplastic activity. Glofitamab contains two antigen-recognition sites: one for human CD3, a T cell surface antigen, and one for human CD20, a tumor-associated antigen (TAA) that is exclusively expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell malignancies. Upon administration, glofitamab binds to both T-cells and CD20-expressing B-lineage tumor cells. The resulting cross-linkage may trigger a potent cytotoxic T-lymphocyte (CTL) response against the CD20-expressing tumor B-cells.

Diseases for which it is used

• Diffuse large B-cell lymphoma
• Transformed lymphoma

1. NP30179: Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wróbel T, Offner F, Trněný M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. Epub 2022 Dec 11. link to original article PubMed Clinical Trial Registry

History of changes in FDA indication

• 2023-06-15: Initial accelerated approval for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. (Based on NP30179)

Also known as

• Code name: RO 7082859
• Generic name: glofitamab-gxbm
• Brand name: Columvi