Genmab gets EPKINLY FDA approval for diffuse large B-cell lymphoma

Danish biotech company Genmab has secured accelerated approval for EPKINLY (epcoritamab-bysp) from the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults.

The T-cell engaging bispecific antibody is indicated for diffuse large B-cell lymphoma resulting from indolent lymphoma, and high-grade B‑cell lymphoma, following a couple of or more lines of systemic therapy.

EPKINLY received the FDA accelerated approval based on its high response rate and durable response. However, continued approval for this indication is dependent on confirming and describing the clinical benefits through additional trial(s).

Genmab and AbbVie are collaborating on the co-development and co-commercialization of EPKINLY, an IgG1-bispecific antibody, as part of their oncology partnership.

EPKINLY employs a dual-targeted approach by continuously binding to both T-cells and CD20+ lymphoma B-cells. It has been developed using Genmab’s proprietary DuoBody technology and is administered subcutaneously.

Genmab’s DuoBody-CD3 technology is designed to selectively direct cytotoxic T-cells to elicit an immune response against specific target cells.

Danish biotech company Genmab gets EPKINLY FDA accelerated approval for diffuse large B-cell lymphoma. Image courtesy of Genmab, All rights reserved. © 2023 Genmab A/S”

Jan van de Winkel — Genmab CEO said: “The approval of EPKINLY in the U.S. is an incredibly important milestone for patients with relapsed or refractory DLBCL, who are in need of a new, innovative treatment option administered subcutaneously.

“As the first and only bispecific antibody approved in the U.S. to treat relapsed or refractory DLBCL, and the third approved medicine developed using Genmab’s DuoBody technology, EPKINLY is a testament to our dedication to turn novel science into medicine and develop innovative and differentiated antibody therapeutics with the goal of improving the lives of patients.”

In a phase 2 clinical study, EPKINLY demonstrated promising results as a subcutaneous monotherapy in challenging-to-treat, relapsed, or refractory DLBCL patients who had undergone at least two prior treatments.

The mid-stage clinical trial showed an overall response rate of 61%, with 90 out of 148 patients achieving a response, and a complete remission rate of 38%. The median duration of response was 15.6 months.