TEPKINLY (epcoritamab) receives second approval from the European Commission for the treatment of adults with relapsed/refractory follicular lymphoma

Company announcement

• TEPKINLY is the first and only subcutaneous bispecific antibody approved as monotherapy in the European Union for the treatment of both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy

COPENHAGEN, Denmark; August 19, 2024 – Genmab A/S
(Nasdaq: GMAB) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY (epcoritamab) as monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell binding bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.

“Follicular lymphoma can be challenging to treat and the approval of TEPKINLY for the treatment of relapsed/refractory follicular lymphoma after two or more lines of systemic therapy marks an important milestone for patients in the European Union who need more options that balance meaningful efficacy with favorable safety,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. “Together with our partner AbbVie, we are committed to exploring the further development of epcoritamab as a potential core therapy for B-cell malignancies.”