Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells
Genmab has submitted a biologics license application (BLA) to the FDA for subcutaneous epcoritamab to treat patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Large B-cell lymphoma (LBCL) is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally.
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology, which is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells. CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies.
Jan van de Winkel, Ph.D.
“Even with existing therapies to treat these lymphomas, there is a significant medical need for alternative and accessible treatment options for patients who are unable to tolerate current treatments or whose treatments have failed,” Jan van de Winkel, Ph.D., chief executive officer of Genmab, said in a press release.
Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. AbbVie has submitted a marketing authorization application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), which has been validated by the European Medicines Agency (EMA).
The regulatory submissions are supported by previously announced results from the LBCL cohort of the pivotal EPCORE NHL-1 phase 2 clinical trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL. These results were presented at the 27th Annual Meeting of the European Hematology Association (EHA2022), on June 11, 2022.
Iowa Expands PBM Legislation to Address Concerns of Independent Pharmacies
May 16th 2025A new law in Iowa, if signed by the governor, will mandate 100% pass-through of rebates, increased financial transparency, and a minimal payment for pharmacies. Critics say it will be the most costly mandate in the state’s history.
Read More
Survey Reveals Cancer Doctors Struggle to Keep Up as Treatments Advance Quickly
May 11th 2025A new survey by Johnson & Johnson revealed that oncologists are overwhelmed by the rapid pace of innovation in cancer care, with many calling for better tools, education and collaboration to help integrate new treatments and technologies into everyday practice.
Read More
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
Listen
The first CAR-T cell therapy was developed and approved by the FDA in 2017 to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Since then, six additional CAR-T cell therapies have been introduced to the market. Four of the seven are approved for B-cell lymphomas.
Read More