European Commission approval of Tepkinly (epcoritamab) for adults with relapsed or refractory diffuse large B-cell lymphoma.- AbbVie.

AbbVie announced that the European Commission (EC) has granted 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. 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.

DLBCL is the most common type of B-cell non-Hodgkin's lymphoma worldwide. While patients may have access to chemoimmunotherapy regimens to treat their disease, they face limited treatment options, with few readily available, off-the-shelf medicines, especially for those whose disease has relapsed or become refractory to prior treatments.

This conditional approval is supported by data from the pivotal EPCORE NHL-1 Phase 1/II open-label, multi-cohort, multi-center, 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 this study, DLBCL patients treated with Tepkinly (N=139) achieved an overall response rate of 62 percent and a complete response rate of 39 percent. The median duration of response was 15.5 months (range: 9.7, not reached).