EC Grants Conditional Marketing Authorization to Epcoritamab for Relapsed, Refractory DLBCL

The European Commission (EC) has granted conditional marketing authorization to epcoritamab (TEPKINLY) as a monotherapy for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

The subcutaneous T-cell engaging bispecific antibody is now approved for the treatment of this patient population in the European Union, as well as Liechtenstein, Norway, and Iceland, according to an announcement from Genmab, the manufacturer of the drug.

This conditional approval is supported by data from the pivotal EPCORE NHL-1 trial. The single-arm phase I/II trial evaluated the preliminary efficacy and safety of epcoritamab. It included 139 patients with DLBCL who showed an overall response rate of 62%, with a complete response rate of 39%. The median duration of response was 15.5 months.

Epcoritamab is being co-developed by AbbVie and Genmab. The companies will share commercial responsibilities in the United States and Japan.