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 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623023 |
| 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.[4][7] Epcoritamab is a bispecific CD20-directed CD3 T-cell engager.[4][7] Epcoritamab was co-developed by AbbVie and Genmab.[8]
Epcoritamab was approved for medical use in the United States in May 2023,[4][7][9][8][10][11] in the European Union in September 2023,[6] and in Canada in December 2023.[1]
Medical uses[edit]
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.[4][7][9]
Side effects[edit]
The most common adverse reactions include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.[7]
History[edit]
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.[7]
The efficacy outcome measure was overall response rate (ORR), which was 61%. Of those patients, 38% of patients achieved complete response.[7]
Society and culture[edit]
Legal status[edit]
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).[12] It was approved for medical use in the European Union in September 2023.[5] The EMA granted orphan drug designation to epcoritamab in both February and June 2022.[13][14][15]
Names[edit]
Epcoritamab is the international nonproprietary name.[16][17]
References[edit]
- ^ a b "Epkinly Product information". Health Canada. 22 October 2009. Retrieved 3 March 2024.
- ^ "Details for: Epkinly". Health Canada. 18 December 2023. Retrieved 3 March 2024.
- ^ "Summary Basis of Decision (SBD) for Epkinly". Drug and Health Products Portal. 1 September 2012. Retrieved 9 May 2024.
- ^ a b c d e "Epcoritamab-bysp- epcoritamab injection, solution Epcoritamab-bysp- epcoritamab injection, solution, concentrate". DailyMed. 16 May 2023. Archived from the original on 25 May 2023. Retrieved 24 May 2023.
- ^ a b "Tepkinly Product information". Union Register of medicinal products. 25 September 2023. Retrieved 1 October 2023.
- ^ a b "Tepkinly EPAR". European Medicines Agency. 5 October 2023. Retrieved 5 October 2023.
- ^ a b c d e f g This article incorporates text from this source, which is in the public domain.
- ^ a b "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.
- ^ a b This article incorporates text from this source, which is in the public domain.
- ^ "Drug Approval Package: Epkinly". U.S. Food and Drug Administration (FDA). 26 May 2023. Retrieved 30 May 2023.
- ^ Frampton JE (September 2023). "Epcoritamab: First Approval". Drugs. 83 (14): 1331–1340. doi:10.1007/s40265-023-01930-4. PMID 37597091. S2CID 261030074.
- ^ "Tepkinly: Pending EC decision". European Medicines Agency (EMA). 21 July 2023. Retrieved 1 October 2023.
- ^ "EU/3/22/2581: Orphan designation for the treatment of diffuse large B-cell lymphoma". European Medicines Agency (EMA). 21 July 2023. Retrieved 1 October 2023.
- ^ "EU/3/22/2634: Orphan designation for the treatment of follicular lymphoma". European Medicines Agency (EMA). 10 May 2023. Retrieved 1 October 2023.
- ^ "EU/3/22/2581". Union Register of medicinal products. 25 September 2023. Retrieved 1 October 2023.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
- ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.
Further reading[edit]
- Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, et al. (April 2023). "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. doi:10.1200/JCO.22.01725. PMC 10115554. PMID 36548927.
- van der Horst HJ, de Jonge AV, Hiemstra IH, Gelderloos AT, Berry DR, Hijmering NJ, et al. (February 2021). "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. doi:10.1038/s41408-021-00430-6. PMC 7892878. PMID 33602901.
External links[edit]
- 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
