Glofitamab
Medication
From Wikipedia, the free encyclopedia
Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma.[9] It is a bispecific CD20-directed CD3 T-cell engager developed by Roche.[6]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CD20 and CD3 |
| Clinical data | |
| Trade names | Columvi |
| Other names | RO7082859, glofitamab-gxbm |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C8632H13326N2296O2701S58 |
| Molar mass | 194344.41 g·mol−1 |
The most common side effects include cytokine release syndrome, muscle and bone pain, rash, and tiredness.[10]
It was approved for medical use in Canada in July 2023,[2][11] in the United States in June 2023,[12][13] and in the European Union in July 2023.[7][14]
Medical uses
Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[6][12] Specifically it is indicated for the treatment of adults with certain types of diffuse large B-cell lymphoma or large B-cell lymphoma who have received at least two prior treatments that did not work or are no longer working.[10]
Adverse effects
The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome.[12] A report in January 2026 from Genentech warned that Glofitamab causes the cytokine release syndrome at rates of 1 to 20% in different studies when used to treat patients with lymphomas.[15]
History
The FDA approved glofitamab based on evidence from a clinical trial NP30179 (NCT03075696) of 145 participants with large B-cell lymphoma who received at least one dose of glofitamab.[10] The efficacy of glofitamab was assessed in 132 participants with de novo diffuse large B‑cell lymphoma, not otherwise specified (80%) or large B-cell lymphoma arising from follicular lymphoma (20%), who have received at least two prior lines of therapy and who received at least one dose of glofitamab.[10] The trial was conducted at 32 sites in 13 of countries in Australia, Belgium, Canada, Czech Republic, Denmark, Spain, Finland, France, Italy, New Zealand, Poland, Taiwan, and the United States.[10] The benefit and side effects of glofitamab were also evaluated in the clinical trial.[10] All participants received glofitamab until the disease progressed or the side effects became too toxic.[10]
Society and culture
Legal status
In April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Columvi, intended for the treatment of diffuse large B‑cell lymphoma (DLBCL).[16] The applicant for this medicinal product is Roche Registration GmbH.[16] Glofitamab was approved for medical use in the European Union in July 2023.[7]
Names
Glofitamab is the international nonproprietary name.[17]
