Glofitamab

Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of diffuse large B-cell lymphoma.[7] It is a bispecific CD20-directed CD3 T-cell engager.[4]

Glofitamab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCD20 and CD3
Clinical data
Trade namesColumvi
Other namesRO7082859, glofitamab-gxbm
License data
Routes of
administration		Intravenous
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC8632H13326N2296O2701S58
Molar mass194344.41 g·mol−1

It was approved for medical use in Canada in March 2023,[8] in the United States in June 2023,[9][10] and in the European Union in July 2023.[5][11]

Medical uses

Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[4][9]

Adverse effects

The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome.[9]

Society and culture

On 26 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).[12] The applicant for this medicinal product is Roche Registration GmbH.[12] Glofitamab was approved for medical use in the European Union in July 2023.[5]

Names

Glofitamab is the international nonproprietary name.[13]

References
  1. "Columvi Product information". Health Canada. 24 March 2023. Archived from the original on 25 April 2023. Retrieved 25 April 2023.
  2. "Register of Innovative Drugs" (PDF). Health Canada. 30 March 2023. Archived (PDF) from the original on 26 June 2020. Retrieved 24 April 2023.
  3. "Summary Basis of Decision for Columvi". Health Canada. 31 May 2023. Archived from the original on 14 July 2023. Retrieved 18 June 2023.
  4. "Columvi- glofitamab concentrate Columvi- glofitamab solution, concentrate". DailyMed. 15 June 2023. Archived from the original on 14 July 2023. Retrieved 26 June 2023.
  5. "Columvi". Union Register of medicinal products. 10 July 2023. Archived from the original on 14 July 2023. Retrieved 14 July 2023.
  6. "Columvi EPAR". European Medicines Agency. 18 July 2023. Archived from the original on 26 July 2023. Retrieved 25 August 2023.
  7. "Archived copy" (PDF). Archived (PDF) from the original on 25 April 2023. Retrieved 25 April 2023.{{cite web}}: CS1 maint: archived copy as title (link)
  8. "Columvi (Glofitamab for Injection) Receives Health Canada Authorization with Conditions for Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma" (Press release). Roche Canada. 25 March 2023. Archived from the original on 25 April 2023. Retrieved 24 April 2023 – via Cision Canada.
  9. "FDA Roundup: June 16, 2023". U.S. Food and Drug Administration (FDA) (Press release). 16 June 2023. Retrieved 16 June 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  10. "FDA approves Roche's Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma" (Press release). F. Hoffmann-La Roche Ltd. 16 June 2023. Retrieved 16 June 2023 – via GlobeNewswire.
  11. "European Commission approves Roche's fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma" (Press release). Roche. 11 July 2023. Archived from the original on 14 July 2023. Retrieved 14 July 2023 – via GlobeNewswire.
  12. "Columvi: Pending EC decision". European Medicines Agency. 26 April 2023. Archived from the original on 28 April 2023. Retrieved 27 April 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

Further reading
  • Clinical trial number NCT03075696 for "A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma" at ClinicalTrials.gov
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