FDA Approves AbbVie's Epcoritamab as the First Bispecific Antibody for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R) in Adults

Tuesday, May 30, 2023

AbbVie announced on May 19, 2023, that the U.S. Food and Drug Administration (FDA) has granted approval for epcoritamab, making it the first bispecific antibody approved for the treatment of relapsed and refractory diffuse large B-cell lymphoma (R/R) in adult patients who have failed two or more prior lines of therapy. The rapid FDA approval of epcoritamab was based on its promising response rate and durability observed in clinical trials. This innovative treatment is a result of a collaboration between AbbVie and Genmab within their oncology partnership.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive form of non-Hodgkin's lymphoma that develops in the lymphatic system and primarily affects B cells, a type of white blood cell. Globally, DLBCL accounts for a significant number of new cases each year, although the specific estimate provided in the original text is not accurate.

Epcoritamab represents a significant advancement in the treatment of relapsed and refractory DLBCL, offering a novel therapeutic option for patients who have not responded to previous treatments. It is administered subcutaneously and provides a new mechanism of action, presenting a non-chemotherapy alternative for physicians and patients. Dr. Thomas Hudson, Senior Vice President of Research and Development and Chief Scientific Officer at AbbVie, expressed the importance of FDA approval and the collaborative efforts with Genmab in developing vital therapies for patients with B-cell malignancies.

In Brazil, the National Cancer Institute (INCA) estimates a significant number of new cases of non-Hodgkin's lymphoma each year, but the specific figures provided in the original text are not accurate.

AbbVie is committed to advancing research and development to redefine the standard of care for different blood cancers. The approval of epcoritamab in the United States marks a significant milestone in the treatment of DLBCL, addressing unmet medical needs. The approval in Brazil is expected to bring benefits to Brazilian patients as well, reinforcing AbbVie's dedication to improving patient outcomes.

Epcoritamab is a bispecific IgG1 antibody developed using Genmab's DuoBody technology. This innovative technology allows simultaneous targeting of CD3 on T cells and CD20 on B cells, resulting in T cell-mediated killing of CD20 cells. AbbVie and Genmab continue to evaluate epcoritamab in clinical studies, including a Phase 3 trial assessing its use as monotherapy in relapsed and refractory DLBCL patients and two Phase 1 studies investigating combination regimens for newly diagnosed DLBCL patients and relapsed and refractory follicular lymphoma.



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