Monoclonal antibody | |
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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 | |
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Identifiers | |
CAS Number | |
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KEGG | |
Chemical and physical data | |
Formula | C8632H13326N2296O2701S58 |
Molar mass | 194344.41 g·mol−1 |
Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma. [10] It is a bispecific CD20-directed CD3 T-cell engager. [7]
The most common side effects include cytokine release syndrome, muscle and bone pain, rash, and tiredness. [11]
It was approved for medical use in Canada in July 2023, [3] [12] in the United States in June 2023, [13] [14] and in the European Union in July 2023. [8] [15]
Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma. [7] [13] 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. [11]
The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome. [13]
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. [11] 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. [11] 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. [11] The benefit and side effects of glofitamab were also evaluated in the clinical trial. [11] All participants received glofitamab until the disease progressed or the side effects became too toxic. [11]
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. [8]
Glofitamab is the international nonproprietary name. [17]