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.[10] It is a bispecific CD20-directed CD3 T-cell engager developed by Roche.[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]

Medical uses

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]

Adverse effects

The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome.[13]

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.[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]

Society and culture

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]

Names

Glofitamab is the international nonproprietary name.[17]

References

  1. ^ a b "Columvi". Therapeutic Goods Administration (TGA). 23 August 2023. Archived from the original on 2 January 2024. Retrieved 8 March 2024.
  2. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  3. ^ a b "Columvi Product information". Health Canada. 24 March 2023. Archived from the original on 25 April 2023. Retrieved 25 April 2023.
  4. ^ "Register of Innovative Drugs" (PDF). Health Canada. 30 March 2023. Archived (PDF) from the original on 26 June 2020. Retrieved 24 April 2023.
  5. ^ "Summary Basis of Decision for Columvi". Health Canada. 31 May 2023. Archived from the original on 14 July 2023. Retrieved 18 June 2023.
  6. ^ "Details for: Columvi". Health Canada. 5 July 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  7. ^ a b c "Columvi- glofitamab concentrate Columvi- glofitamab solution, concentrate". DailyMed. 15 June 2023. Archived from the original on 14 July 2023. Retrieved 26 June 2023.
  8. ^ a b c "Columvi". Union Register of medicinal products. 10 July 2023. Archived from the original on 14 July 2023. Retrieved 14 July 2023.
  9. ^ "Columvi EPAR". European Medicines Agency. 18 July 2023. Archived from the original on 26 July 2023. Retrieved 25 August 2023.
  10. ^ "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.
  11. ^ a b c d e f g "Drug Trials Snapshots: Columvi". U.S. Food and Drug Administration. 15 June 2023. Retrieved 23 March 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  12. ^ "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.
  13. ^ a b c "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. Public Domain This article incorporates text from this source, which is in the public domain.
  14. ^ "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.
  15. ^ "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.
  16. ^ a b "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.
  17. ^ 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