Glofitamab Explained

Type:mab
Mab Type:mab
Source:zu
Target:CD20 and CD3
Tradename:Columvi
Dailymedid:Glofitamab
Pregnancy Au:C
Routes Of Administration:Intravenous
Class:Antineoplastic
Atc Prefix:L01
Atc Suffix:FX28
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[2] [3] [4] [5]
Legal Us:Rx-only
Legal Us Comment:[6]
Legal Eu:Rx-only
Legal Eu Comment:[7] [8]
Cas Number:2229047-91-8
Drugbank:DB16371
Unii:06P3KLK2J8
Kegg:D11833
Synonyms:RO7082859, glofitamab-gxbm
C:8632
H:13326
N:2296
O:2701
S:58

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.

The most common side effects include cytokine release syndrome, muscle and bone pain, rash, and tiredness.

It was approved for medical use in Canada in July 2023,[10] in the United States in June 2023,[11] [12] and in the European Union in July 2023.[13]

Medical uses

Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma. 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.[14]

Adverse effects

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

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

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). The applicant for this medicinal product is Roche Registration GmbH.[15] Glofitamab was approved for medical use in the European Union in July 2023.

Names

Glofitamab is the international nonproprietary name.[16]

Further reading

Notes and References

  1. Web site: Columvi . Therapeutic Goods Administration (TGA) . 23 August 2023 . 8 March 2024 . 2 January 2024 . https://web.archive.org/web/20240102021526/https://www.tga.gov.au/resources/auspmd/columvi . live .
  2. Web site: Columvi Product information . . 24 March 2023 . 25 April 2023 . 25 April 2023 . https://web.archive.org/web/20230425040747/https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102531 . live .
  3. Web site: Register of Innovative Drugs . . 30 March 2023 . 24 April 2023 . 26 June 2020 . https://web.archive.org/web/20200626124518/https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/reg-innov-dr-eng.pdf . live .
  4. Web site: Summary Basis of Decision for Columvi . . 31 May 2023 . 18 June 2023 . 14 July 2023 . https://web.archive.org/web/20230714201716/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1685634038615 . live .
  5. Web site: Details for: Columvi . . 5 July 2023 . 3 March 2024 . 3 March 2024 . https://web.archive.org/web/20240303050532/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102531 . live .
  6. Web site: Columvi- glofitamab concentrate Columvi- glofitamab solution, concentrate . DailyMed . 15 June 2023 . 26 June 2023 . 14 July 2023 . https://web.archive.org/web/20230714201711/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d . live .
  7. Web site: Columvi . Union Register of medicinal products . 10 July 2023 . 14 July 2023 . 14 July 2023 . https://web.archive.org/web/20230714201714/https://ec.europa.eu/health/documents/community-register/html/h1742.htm . live .
  8. Web site: Columvi EPAR . European Medicines Agency . 18 July 2023 . 25 August 2023 . 26 July 2023 . https://web.archive.org/web/20230726041814/https://www.ema.europa.eu/en/medicines/human/EPAR/columvi . live .
  9. Web site: Columvi glofitamab for injection Product Monograph . Hoffmann-La Roche Limited . 24 March 2023 . . 25 April 2023 . 25 April 2023 . https://web.archive.org/web/20230425035246/https://pdf.hres.ca/dpd_pm/00070059.PDF . live .
  10. Columvi (Glofitamab for Injection) Receives Health Canada Authorization with Conditions for Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma . Roche Canada . Cision Canada . 25 March 2023 . 24 April 2023 . 25 April 2023 . https://web.archive.org/web/20230425035245/https://www.newswire.ca/news-releases/columvi-r-glofitamab-for-injection-receives-health-canada-authorization-with-conditions-for-adult-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-872796257.html . live .
  11. FDA Roundup: June 16, 2023 . U.S. Food and Drug Administration (FDA) . 16 June 2023 . 16 June 2023 . 17 June 2023 . https://web.archive.org/web/20230617052152/https://www.fda.gov/news-events/press-announcements/fda-roundup-june-16-2023 . live .
  12. 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 . F. Hoffmann-La Roche Ltd . GlobeNewswire . 16 June 2023 . 16 June 2023 . 16 June 2023 . https://web.archive.org/web/20230616201003/https://www.globenewswire.com/news-release/2023/06/16/2689505/0/en/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.html . live .
  13. European Commission approves Roche's fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma . Roche . GlobeNewswire . 11 July 2023 . 14 July 2023 . 14 July 2023 . https://web.archive.org/web/20230714201749/https://www.globenewswire.com/news-release/2023/07/11/2702272/0/en/European-Commission-approves-Roche-s-fixed-duration-Columvi-glofitamab-for-people-with-relapsed-or-refractory-diffuse-large-B-cell-lymphoma.html . live .
  14. Web site: Drug Trials Snapshots: Columvi . U.S. Food and Drug Administration . 15 June 2023 . 23 March 2024.
  15. Web site: Columvi: Pending EC decision . European Medicines Agency . 26 April 2023 . 27 April 2023 . 28 April 2023 . https://web.archive.org/web/20230428051314/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/columvi . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. ((World Health Organization)) . 2020 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 . WHO Drug Information . 34 . 1 . 10665/339768 . free . World Health Organization .

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