Chemistry:Epcoritamab
| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Humanized |
| Target | CD3E, CD20 |
| Clinical data | |
| Trade names | Epkinly, Tepkinly |
| Other names | epcoritamab-bysp, GEN3013 |
| License data |
|
| Routes of administration | Subcutaneous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6471H9999N1735O2007S44 |
| Molar mass | 145624.95 g·mol−1 |
Epcoritamab, sold under the brand name Epkinly, is a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma.[1][4] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager.[1][4] Epcoritamab was co-developed by AbbVie and Genmab.[5]
Epcoritamab was approved for medical use in the United States in May 2023,[1][4][6][5][7][8] and in the European Union in September 2023.
Medical uses
Epcoritamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.[1][4][6]
Side effects
The most common adverse reactions include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.[4]
History
Epcoritamab was evaluated in the EPCORE NHL-1 (NCT03625037) trial in 148 participants with relapsed or refractory B-cell lymphoma after two or more lines of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.[4]
The efficacy outcome measure was overall response rate (ORR), which was 61%. Of those patients, 38% of patients achieved complete response.[4]
Society and culture
Legal status
In July 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended a conditional marketing authorization for epcoritamab (Tepkinly).[9] It was approved for medical use in the European Union in September 2023.[2] The EMA granted orphan drug designation to epcoritamab in both February and June 2022.[10][11][12]
Names
Epcoritamab is the international nonproprietary name.[13][14]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Epcoritamab-bysp- epcoritamab injection, solution Epcoritamab-bysp- epcoritamab injection, solution, concentrate". 16 May 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7836711-b677-412d-bf2d-0f7c8444103a.
- ↑ 2.0 2.1 "Tepkinly Product information". 25 September 2023. https://ec.europa.eu/health/documents/community-register/html/h1759.htm.
- ↑ "Tepkinly EPAR". 5 October 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly.
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 "FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". 19 May 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell.
This article incorporates text from this source, which is in the public domain.
- ↑ 5.0 5.1 "Epkinly (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)" (Press release). AbbVie. 19 May 2023. Archived from the original on 19 May 2023. Retrieved 20 May 2023 – via PR Newswire.
- ↑ 6.0 6.1 "FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". 19 May 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell. This article incorporates text from this source, which is in the public domain.
- ↑ "Drug Approval Package: Epkinly". 26 May 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761324Orig1s000TOC.cfm.
- ↑ "Epcoritamab: First Approval". Drugs 83 (14): 1331–1340. September 2023. doi:10.1007/s40265-023-01930-4. PMID 37597091.
- ↑ "Tepkinly: Pending EC decision". 21 July 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tepkinly.
- ↑ "EU/3/22/2581: Orphan designation for the treatment of diffuse large B-cell lymphoma". 21 July 2023. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2581.
- ↑ "EU/3/22/2634: Orphan designation for the treatment of follicular lymphoma". 10 May 2023. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-22-2634.
- ↑ "EU/3/22/2581". 25 September 2023. https://ec.europa.eu/health/documents/community-register/html/o2581.htm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information 36 (3). 2022.
Further reading
- "Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial". Journal of Clinical Oncology 41 (12): 2238–2247. April 2023. doi:10.1200/JCO.22.01725. PMID 36548927.
- "Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment". Blood Cancer Journal 11 (2): 38. February 2021. doi:10.1038/s41408-021-00430-6. PMID 33602901.
External links
- Clinical trial number NCT03625037 for "First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE NHL-1)" at ClinicalTrials.gov
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