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# Epcoritamab Breakthrough Status in Follicular Lymphoma
- URL: https://www.fdaweb.com/epcoritamab-breakthrough-status-in-follicular-lymphoma/
- Published: 2023-12-01T12:00:00.000Z
- Updated: 2026-09-14T14:17:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155901

FDA has granted Genmab a breakthrough therapy designation for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Epcoritamab, under the brand name Epkinly, is currently FDA-approved for certain lymphoma indications.

The IgG1-bispecific antibody was created using Genmab's proprietary DuoBody technology, and is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types, according to the company. “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,” it says.

Genmab says the breakthrough status was based on previously [announced](https://www.globenewswire.com/Tracker?data=SPD5PRVoJEy6GlOWZNHIa9SjrW4o%5FYovd-HbslmDaVkDLii4U1xUXQlKDMmiJqy-tl2tY8dDSPTJxCpZHvLgnGNkSqP1pIzeuoGWUAae2GYZHQqqio3qUXLUOgz1l3-Cx4TgcJFnwLxnYS7%5FT56O65LkMdhevBgsxGl9ZSiADNGCsiK5lsGGeP1F4svLZavq-6zmyeE2349Ib9DyZsaE8w==&ref=fdaweb.com) results from the Phase 1/2 EPCORE NHL-1 clinical trial in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma, including FL. Updated results will be presented at the American Society of Hematology’s annual meeting 12/9-12.