Glofitamab

Glofitamab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCD20 and CD3
Clinical data
Trade namesColumvi
Other namesRO7082859, glofitamab-gxbm
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classAntineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC8632H13326N2296O2701S58
Molar mass194344.41 g·mol−1

Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of large B-cell lymphoma.[9] It is a bispecific CD20-directed CD3 T-cell engager developed by Roche.[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]

  1. ^ a b "Columvi". Therapeutic Goods Administration (TGA). 23 August 2023. Archived from the original on 2 January 2024. Retrieved 8 March 2024.
  2. ^ a b "Columvi Product information". Health Canada. 24 March 2023. Archived from the original on 25 April 2023. Retrieved 25 April 2023.
  3. ^ "Register of Innovative Drugs" (PDF). Health Canada. 30 March 2023. Archived (PDF) from the original on 26 June 2020. Retrieved 24 April 2023.
  4. ^ "Summary Basis of Decision for Columvi". Health Canada. 31 May 2023. Archived from the original on 14 July 2023. Retrieved 18 June 2023.
  5. ^ "Details for: Columvi". Health Canada. 5 July 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  6. ^ a b "Columvi- glofitamab concentrate Columvi- glofitamab solution, concentrate". DailyMed. 15 June 2023. Archived from the original on 14 July 2023. Retrieved 26 June 2023.
  7. ^ a b "Columvi". Union Register of medicinal products. 10 July 2023. Archived from the original on 14 July 2023. Retrieved 14 July 2023.
  8. ^ "Columvi EPAR". European Medicines Agency. 18 July 2023. Archived from the original on 26 July 2023. Retrieved 25 August 2023.
  9. ^ "Columvi glofitamab for injection Product Monograph" (PDF). Hoffmann-La Roche Limited. Health Canada. 24 March 2023. Archived (PDF) from the original on 25 April 2023. Retrieved 25 April 2023.
  10. ^ Cite error: The named reference Columvi FDA snapshot was invoked but never defined (see the help page).
  11. ^ "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.
  12. ^ "FDA Roundup: June 16, 2023". U.S. Food and Drug Administration (FDA) (Press release). 16 June 2023. Archived from the original on 17 June 2023. Retrieved 16 June 2023. This article incorporates text from this source, which is in the public domain.
  13. ^ "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. Archived from the original on 16 June 2023. Retrieved 16 June 2023 – via GlobeNewswire.
  14. ^ "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.
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