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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).

Background

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)

FDA Approved Products

EPKINLY
Manufacturer:Genmab US, Inc.
Route:SUBCUTANEOUS
Strength:4 mg in 0.8 mL
Approved: 2023/05/16
NDC:82705-002
EPKINLY
Manufacturer:Genmab US, Inc.
Route:SUBCUTANEOUS
Strength:48 mg in 0.8 mL
Approved: 2023/05/16
NDC:82705-010

Singapore Approved Products

EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG
Form:INJECTION, SOLUTION, CONCENTRATE
Strength:4.0mg/0.8mL
Online:Yes
Approved: 2024/10/02
Approval:SIN17105P
EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG
Form:INJECTION, SOLUTION
Strength:48mg/0.8mL
Online:Yes
Approved: 2024/10/02
Approval:SIN17106P

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