Chemistry:Glofitamab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CD20 and CD3 |
| Clinical data | |
| Trade names | Columvi |
| Other names | RO7082859, glofitamab-gxbm |
| License data |
|
| Pregnancy category |
|
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C8632H13326N2296O2701S58 |
| Molar mass | 194344.41 g·mol−1 |
Glofitamab, sold under the brand name Columvi, is a bispecific monoclonal antibody used for the treatment of diffuse large B-cell lymphoma.[8] It is a bispecific CD20-directed CD3 T-cell engager.[5]
It was approved for medical use in Canada in March 2023,[9] in the United States in June 2023,[10][11] and in the European Union in July 2023.[6][12]
Medical uses
Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[5][10]
Adverse effects
The US Food and Drug Administration (FDA) label includes a boxed warning for serious or fatal cytokine release syndrome.[10]
Society and culture
Legal status
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).[13] The applicant for this medicinal product is Roche Registration GmbH.[13] Glofitamab was approved for medical use in the European Union in July 2023.[6]
Names
Glofitamab is the international nonproprietary name.[14]
References
- ↑ 1.0 1.1 https://www.tga.gov.au/resources/auspmd/columvi
- ↑ "Columvi Product information". 24 March 2023. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102531.
- ↑ "Register of Innovative Drugs". 30 March 2023. 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.
- ↑ "Summary Basis of Decision for Columvi". 31 May 2023. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1685634038615.
- ↑ 5.0 5.1 5.2 "Columvi- glofitamab concentrate Columvi- glofitamab solution, concentrate". 15 June 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d.
- ↑ 6.0 6.1 6.2 "Columvi". 10 July 2023. https://ec.europa.eu/health/documents/community-register/html/h1742.htm.
- ↑ "Columvi EPAR". 18 July 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/columvi.
- ↑ "PrCOLUMVI glofitamab for injection Product Monograph". Hoffmann-La Roche Limited. Health Canada. 24 March 2023. https://pdf.hres.ca/dpd_pm/00070059.PDF.
- ↑ "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.
- ↑ 10.0 10.1 10.2 "FDA Roundup: June 16, 2023". U.S. Food and Drug Administration (FDA) (Press release). 16 June 2023. Retrieved 16 June 2023.
This article incorporates text from this source, which is in the public domain.
- ↑ "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.
- ↑ "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.
- ↑ 13.0 13.1 "Columvi: Pending EC decision". 26 April 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/columvi. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020.
Further reading
- "Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial". Journal of Clinical Oncology 39 (18): 1959–1970. June 2021. doi:10.1200/JCO.20.03175. PMID 33739857.
- "Bispecific Antibodies: A Review of Development, Clinical Efficacy and Toxicity in B-Cell Lymphomas". Journal of Personalized Medicine 11 (5): 355. April 2021. doi:10.3390/jpm11050355. PMID 33946635.
- "Ten years in the making: application of CrossMab technology for the development of therapeutic bispecific antibodies and antibody fusion proteins". mAbs 13 (1): 1967714. 2021. doi:10.1080/19420862.2021.1967714. PMID 34491877.
External links
- 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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