Epcoritamab 48mg/0.8ml solution for injection vials

Epcoritamab is an IgG1-bispecific antibody that simultaneously binds to CD3 on T-cells and CD20 on B-cells.[A259736][A258488][A259761][L46516] 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.[A259761][L46516] 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.[A259736][A258488] The use of epcoritamab in this group of patients has high response rates, durable complete responses and manageable adverse events with few discontinuations.[A259736]

The use of epcoritamab may lead to cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.[L46516] 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).[L46516][L46556] In September 2023, epcoritamab was also approved in the EU for the same indication.[L49464] In November 2025, epcoritamab in combination with rituximab and lenalidomide was approved by the FDA for adult patients with relapsed or refractory follicular lymphoma.[L54713]