Epcoritamab

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	US DailyMed: Epcoritamab
Routes of administration	Subcutaneous
Drug class	Antineoplastic
ATC code	L01FX27 (WHO)
Legal status
Legal status	CA: ℞-only / Schedule D^[1]^[2]^[3] US: ℞-only^[4] EU: Rx-only^[5]^[6]
Identifiers
CAS Number	2134641-34-0
DrugBank	DB16672
UNII	D6OMY2L0WA
KEGG	D12368
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]

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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.^[4]^[7]^[9]

Side effects

The most common adverse reactions include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.^[7]

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.
^ 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.

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

Monoclonal antibodies for tumors

Tumor

Human	Adecatumumab^§ Amivantamab Ascrinvacumab^§ Atezolizumab Balstilimab^† Botensilimab Cixutumumab^§ Conatumumab^§ Daratumumab Drozitumab^§ Duligotumab^§ Dusigitumab^§ Enfortumab vedotin Enoticumab^§ Figitumumab^§ Flanvotumab^§ Ganitumab^† Glembatumumab vedotin^† Intetumumab^§ Ipilimumab Iratumumab^§ Istiratumab Icrucumab^§ Lexatumumab^§ Lucatumumab^§ Mapatumumab^§ Narnatumab^§ Necitumumab Nesvacumab^§ Nivolumab^# Ofatumumab Olaratumab^† Panitumumab Patritumab^§ Pembrolizumab^# Pritumumab^§ Radretumab^§ Ramucirumab Rilotumumab^† Robatumumab^§ Seribantumab^§ Tarextumab^§ Tisotumab vedotin Teprotumumab^† Tovetumab^§ Vantictumab^§ Votumumab^§ Zalutumumab^†
Mouse	Abagovomab Altumomab pentetate Anatumomab mafenatox Arcitumomab Bectumomab Blinatumomab Capromab pendetide Detumomab Edrecolomab Ibritumomab tiuxetan Igovomab Lilotomab Minretumomab Mitumomab Nacolomab tafenatox Moxetumomab pasudotox Naptumomab estafenatox Oregovomab Pemtumomab^† Racotumomab Satumomab pendetide Solitomab Taplitumomab paptox Nofetumomab merpentan Pintumomab Tenatumomab Tositumomab
Chimeric	Amatuximab^§ Bavituximab^§ Brentuximab vedotin Carotuximab^† Cetuximab Derlotuximab biotin^§ Dinutuximab Ecromeximab^§ Ensituximab^§ Futuximab^§ Girentuximab^† Indatuximab ravtansine^§ Isatuximab Loncastuximab tesirine Margetuximab Mirvetuximab soravtansine Rituximab^# Siltuximab Ublituximab
Humanized	Abituzumab^§ Alemtuzumab Belantamab mafodotin Bevacizumab Bivatuzumab mertansine^§ Brontictuzumab^§ Cantuzumab mertansine^§ Cantuzumab ravtansine^§ Cirmtuzumab Citatuzumab bogatox^§ Clivatuzumab tetraxetan Cofetuzumab pelidotin Dacetuzumab^§ Demcizumab^§ Dalotuzumab^§ Denintuzumab mafodotin^§ Elotuzumab Emactuzumab Emibetuzumab^§ Enoblituzumab^§ Epcoritamab Etaracizumab^§ Farletuzumab^§ Ficlatuzumab^§ Flotetuzumab^§ Gemtuzumab ozogamicin Glofitamab Imgatuzumab^§ Inotuzumab ozogamicin Labetuzumab^§ Lifastuzumab vedotin^§ Lintuzumab^§ Lorvotuzumab mertansine^§ Lumretuzumab^§ Matuzumab^§ Milatuzumab^§ Naxitamab Nimotuzumab^† Obinutuzumab Ocaratuzumab^§ Otlertuzumab^§ Onartuzumab^§ Oportuzumab monatox^† Parsatuzumab^§ Pertuzumab Pinatuzumab vedotin^§ Polatuzumab vedotin Rosmantuzumab Rovalpituzumab tesirine^† Sacituzumab govitecan Sibrotuzumab^§ Simtuzumab^§ Sofituzumab vedotin^§ Tacatuzumab tetraxetan^§ Tigatuzumab^§ Trastuzumab^# (+deruxtecan / +emtansine) Tucotuzumab celmoleukin^§ Vandortuzumab vedotin^§ Vanucizumab^§ Veltuzumab^§ Vorsetuzumab mafodotin^§
Rat/mouse hybrid	Catumaxomab Ertumaxomab^§
Chimeric + humanized	Depatuxizumab mafodotin^† Duvortuxizumab Ontuxizumab^§

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III

This page was last edited on 3 March 2024, at 04:53

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