| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CD20 andCD3 |
| Clinical data | |
| Trade names | Columvi |
| Other names | RO7082859, glofitamab-gxbm |
| License data | |
| Pregnancy category | |
| 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 |
Glofitamab, sold under the brand nameColumvi, is abispecific monoclonal antibody used for the treatment oflarge B-cell lymphoma.[9] It is a bispecific CD20-directed CD3 T-cell engager developed byRoche.[6]
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]
Glofitamab isindicated 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]
The USFood and Drug Administration (FDA) label includes aboxed warning for serious or fatal cytokine release syndrome.[12]
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]
In April 2023, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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).[15] The applicant for this medicinal product is Roche Registration GmbH.[15] Glofitamab was approved for medical use in the European Union in July 2023.[7]
Glofitamab is theinternational nonproprietary name.[16]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
