EMA Conditional Approval of AbbVie’s Tepkinly (epcoritamab) for R/R Diffuse Large B-cell Lymphoma (DLBCL)
The European Commission (EC) has granted on September 22, 2023 the conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Abbvie reports TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as Liechtenstein, Norway, and Iceland.
The conditional approval was supported by data from the pivotal EPCORE™ NHL-1 Phase 1/2 open-label, multi-cohort, multi-centre, single-arm trial evaluating the preliminary efficacy and safety of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL.
In the study, DLBCL patients treated with TEPKINLY (N=139) achieved an overall response rate of 62% and a complete response rate of 39%. The median duration of response was 15.5 months (range: 9.7, not reached).
The most common adverse reactions (≥ 20%) were cytokine release syndrome, fatigue, neutropenia, injection site reaction, musculoskeletal pain, abdominal pain, pyrexia, nausea and diarrhoea.
TEPKINLY is an IgG1-bispecific antibody created using Genmab's DuoBody® technology. The DuoBody®-CD3 technology is designed to direct cytotoxic T-cells selectively to elicit an immune response toward target cell types. The biologic is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.
Orphan market exclusivity for "Treatment of diffuse large B-cell lymphoma" (based on designation EU/3/22/2581) will expire on 25 Sep 2033 (10 years of market exclusivity).
The U.S. Food and Drug Administration (FDA) approved epcoritamab under the brand name EPKINLY™ (epcoritamab-bysp) in May 2023.