Genmab has received conditional marketing authorisation from the European Commission (EC) for TEPKINLY (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) following two or more lines of systemic therapy.

It is the first and only subcutaneous T-cell-engaging bispecific antibody that has gained approval to treat these patients in the EU, Iceland, Liechtenstein and Norway.

The IgG1-bispecific antibody epcoritamab has been created utilising the company’s DuoBody technology, which selectively directs cytotoxic T-cells to evoke an immune response towards target cell types.

It induces T-cell mediated killing of CD20+ cells by simultaneously binding to CD3 on T-cells and CD20 on B-cells.

The approval was based on data from the pivotal EPCORE NHL-1 Phase I/II multi-cohort, multi-centre, single-arm, open-label study.

It was designed to assess the safety and preliminary efficacy of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

DLBCL patients who received treatment with TEPKINLY attained an overall response rate of 62% and a complete response rate of 39% with a median duration of response of 15.5 months.

TEPKINLY showed a manageable safety profile across the LBCL patient cohort, which included patients with DLBCL.

Genmab CEO Jan van de Winkel stated: “With TEPKINLY, people in Europe living with relapsed or refractory diffuse large B-cell lymphoma who are in need of additional treatment options now have a readily available, innovative therapeutic option for this aggressive cancer.”

Pharmaceutical Technology Excellence Awards - The Benefits of Entering

Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today!

Nominate Now