FDA clears AbbVie-Genmab’s EPKINLY for Relapsed/Refractory DLBCL

The approval was based on results from the Phase 1/2 EPCORE NHL-1 trial, which enrolled 157 patients with large B-cell lymphoma, which included 148 patients with DLBCL or high-grade B-cell lymphoma


AbbVie US Headquarters Angle 3

EPKINLY is a prescription medicine used to treat adults with certain types of DLBCL and HGBL patients. (Credit: AbbVie Inc.)

AbbVie and Genmab have received approval from the US Food and Drug Administration (FDA) for their jointly developed EPKINLY (epcoritamab-bysp) as the first and only bispecific antibody to treat adult patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL).

The T-cell-engaging bispecific antibody is now indicated for DLBCL emerging from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), post two or more systemic therapies.

EPKINLY is a prescription medicine used to treat adults with certain types of DLBCL and HGBL patients. It is based on Genmab’s proprietary DuoBody technology.

The US FDA approved EPKINLY under its Accelerated Approval programme based on response rate and durability of response.

AbbVie chief scientific officer and research and development SVP Thomas Hudson said: “The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients.

“As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off-the-shelf form for physicians.”

The approval was based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which enrolled 157 patients with large B-cell lymphoma (LBCL), which included 148 patients with DLBCL or high-grade B-cell lymphoma.

In the trial, EPKINLY delivered an overall response rate (ORR) of 61%, including a complete response (CR) rate of 38% and a median duration of response of 15.6 months in difficult-to-treat R/R DLBCL patients.

Genmab CEO Jan van de Winkel said: “The approval of EPKINLY in the US 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.”

Both firms are evaluating EPKINLY as a monotherapy, and in combination, in multiple lines of therapy for a range of hematologic malignancies.

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