Epcoritamab
Humanized | |
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Target | CD3E, CD20 |
Clinical data | |
Trade names | Epkinly, Tepkinly |
Other names | epcoritamab-bysp, GEN3013 |
License data |
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Antineoplastic | |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
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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
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
Epcoritamab is
Side effects
The most common adverse reactions include
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.[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
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).[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
Epcoritamab is the international nonproprietary name.[16][17]
References
- ^ a b "Epkinly Product information". Health Canada. 22 October 2009. Retrieved 3 March 2024.
- ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]". Health Canada. 28 February 2024. Retrieved 2 March 2024.
- ^ "Details for: Epkinly". Health Canada. 18 December 2023. Retrieved 3 March 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 "FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". U.S. Food and Drug Administration (FDA). 19 May 2023. Archived from the original on 23 May 2023. Retrieved 24 May 2023. 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 "FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma". U.S. Food and Drug Administration (FDA). 19 May 2023. Archived from the original on 2 June 2023. Retrieved 2 June 2023. 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.
- 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.
- hdl:10665/339768.
- hdl:10665/363551.
Further reading
- 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. 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. 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