Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma. It is a bispecific CD20-directed CD3 T-cell engager developed by Roche.
Medical uses
Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma. == Adverse effects ==
Adverse effects
The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome. 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.
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. 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. 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. The benefit and side effects of glofitamab were also evaluated in the clinical trial. All participants received glofitamab until the disease progressed or the side effects became too toxic. == Society and culture ==
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). Glofitamab was approved for medical use in the European Union in July 2023. == References ==