Difference between revisions of "Glofitamab (Columvi)"
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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/glofitamab 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. | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/glofitamab 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]]=== | ===[[Diffuse large B-cell lymphoma]]=== | ||
#'''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. [https://doi.org/10.1056/nejmoa2206913 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36507690/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT03075696 Clinical Trial Registry] | #'''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. [https://doi.org/10.1056/nejmoa2206913 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36507690/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT03075696 Clinical Trial Registry] | ||
| + | ==History of changes in FDA indication== | ||
| + | *2023-06-15: Initial accelerated approval for relapsed or refractory [[diffuse large B-cell lymphoma|diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)]] or [[Transformed lymphoma|large B-cell lymphoma (LBCL) arising from follicular lymphoma]], after two or more lines of systemic therapy. ''(Based on NP30179)'' | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code | + | *'''Code name:''' RO 7082859 |
| − | + | *'''Generic name:''' glofitamab-gxbm | |
| + | *'''Brand name:''' Columvi | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| Line 16: | Line 19: | ||
[[Category:Anti-CD3 antibodies]] | [[Category:Anti-CD3 antibodies]] | ||
| − | [[Category:Diffuse large B-cell lymphoma medications | + | [[Category:Diffuse large B-cell lymphoma medications]] |
| − | [[Category: | + | [[Category:FDA approved in 2023]] |
Revision as of 20:00, 17 June 2023
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
- 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