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Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Management of Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) by AbbVie

Saturday, July 22, 2023

AbbVie recently made an announcement regarding the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP has recommended granting conditional marketing authorization for epcoritamab (TEPKINLY®) as a monotherapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received two or more lines of systemic therapy. The final decision from the European Commission on this indication is expected later this year.

Epcoritamab is a collaborative development between AbbVie and Genmab, utilizing Genmab's DuoBody® technology. As an investigational IgG1-bispecific antibody, it is designed to selectively target CD20+ cells and trigger a T-cell mediated immune response. CD20 is a clinically validated therapeutic target in various B-cell malignancies, including DLBCL, mantle cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia.

The efficacy and safety of epcoritamab were assessed in the pivotal EPCORE™ NHL-1 Phase 1/2 trial, where it demonstrated an overall response rate of 63.1 percent as evaluated by an independent review committee. The most common treatment-emergent adverse event observed was cytokine release syndrome. Updated results from the trial were presented at various medical congresses.DLBCL is a highly aggressive cancer that affects the lymphatic system and constitutes a significant portion of B-cell NHL cases worldwide.



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