MedPath

Epcoritamab

Generic Name
Epcoritamab
Brand Names
Epkinly, Tepkinly
Drug Type
Biotech
CAS Number
2134641-34-0
Unique Ingredient Identifier
D6OMY2L0WA

Overview

Epcoritamab is an IgG1-bispecific antibody that simultaneously binds to CD3 on T-cells and CD20 on B-cells. Epcoritamab promotes the activation and expansion of T-cells and, by being able to bind to both CD20 and CD3, it leads to the T-cell–mediated killing of CD20+ malignant B cells. Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of cancer commonly treated with several cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Although this regimen is effective in up to 60% of patients, patients with relapsed or refractory DLBCL have poor outcomes. The use of epcoritamab in this group of patients has high response rates, durable complete responses and manageable adverse events with few discontinuations. The use of epcoritamab may lead to cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. It is administered subcutaneously and is currently being evaluated as a monotherapy and in combination for the treatment of a variety of hematologic malignancies. In May 2023, epcoritamab was approved by the FDA under accelerated approval for the treatment of relapsed or refractory DLBCL. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Indication

Epcoritamab is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Associated Conditions

  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Relapsed Diffuse Large B-cell Lymphoma (DLBCL)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/22
Phase 2
Not yet recruiting
2025/04/17
Phase 2
Not yet recruiting
The Lymphoma Academic Research Organisation
2025/04/09
Phase 2
Not yet recruiting
2025/04/01
Phase 2
Not yet recruiting
2025/02/06
Phase 2
Not yet recruiting
2025/01/28
Phase 2
Not yet recruiting
Izidore Lossos, MD
2024/12/09
Phase 2
Not yet recruiting
2024/11/06
Phase 1
Recruiting
2024/11/04
Phase 1
Recruiting
Timothy Voorhees
2024/08/28
Phase 2
Recruiting
City of Hope Medical Center

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Genmab US, Inc.
82705-002
SUBCUTANEOUS
4 mg in 0.8 mL
5/16/2023
Genmab US, Inc.
82705-010
SUBCUTANEOUS
48 mg in 0.8 mL
5/16/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
9/22/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML
SIN17105P
INJECTION, SOLUTION, CONCENTRATE
4.0mg/0.8mL
10/2/2024
EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML
SIN17106P
INJECTION, SOLUTION
48mg/0.8mL
10/2/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML
N/A
N/A
N/A
11/4/2024
EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML
N/A
N/A
N/A
11/4/2024

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
EPKINLY epcoritamab 4mg/0.8mL concentrate solution for injection vial
404978
Medicine
A
1/6/2025
EPKINLY epcoritamab 48mg/0.8mL solution for injection vial
404977
Medicine
A
1/6/2025

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
EPKINLY
02542293
Solution - Subcutaneous
5 MG / ML
12/18/2023
EPKINLY
02542307
Solution - Subcutaneous
60 MG / ML
12/18/2023

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TEPKINLY 48 MG SOLUCION INYECTABLE
1231759002
SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
TEPKINLY 4 MG/0,8 ML SOLUCION INYECTABLE
1231759001
CONCENTRADO PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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