AbbVie Submits Applications for Epcoritamab for Lymphoma Treatments

 

• European Medicines Agency (EMA) validates AbbVie's Marketing Authorization Application; Genmab submits Biologics License Application to U.S. Food and Drug Administration (FDA)
• The submissions are supported by the EPCORE™ NHL-1 open-label, multi-center Phase 2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL)

AbbVie (NYSE: ABBV) today announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody^®-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Additionally, Genmab has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

https://www.biospace.com/article/releases/abbvie-announces-submissions-of-regulatory-applications-for-epcoritamab-duobody-cd3xcd20-for-the-treatment-of-relapsed-refractory-diffuse-large-b-cell-lymphoma-dlbcl-and-large-b-cell-lymphoma-lbcl-/