FDA Approves Epcoritamab, Developed by AbbVie, as the First Bispecific Antibody for the Treatment of Adults with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R)
Tuesday, May 30, 2023
AbbVie, a pharmaceutical company, made an announcement on May 19, 2023, regarding the approval of epcoritamab by the US Food and Drug Administration (FDA). Epcoritamab is a bispecific antibody that has been approved as the first and only treatment option for adult patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) who have failed two or more previous lines of therapy. The rapid approval of epcoritamab by the FDA was attributed to its high response rate and durability as demonstrated in clinical studies. The development of epcoritamab is a result of the collaboration between AbbVie and Genmab under their oncology partnership.
DLBCL is an aggressive form of non-Hodgkin's lymphoma that affects B cells in the lymphatic system. It is estimated that there are approximately 150,000 new cases of DLBCL worldwide each year. Standard treatment for DLBCL usually involves chemo-immunotherapy regimens. However, treatment options for relapsed and refractory patients have been limited, and epcoritamab offers a non-chemotherapy alternative.
Epcoritamab, created using Genmab's proprietary DuoBody technology, is a bispecific IgG1 antibody that targets both the CD3 receptor on T cells and the CD20 receptor on B cells. By engaging these receptors simultaneously, epcoritamab activates T cells to selectively eliminate CD20-expressing B cells.
The approval of epcoritamab in the United States marks a significant advancement in the treatment of DLBCL, addressing the unmet needs of patients. AbbVie also recognizes the potential impact of this approval for Brazilian patients once it receives local approval.
