AbbVie/Genmab’s Epkinly Receives FDA Accelerated Approval for Follicular Lymphoma

AbbVie/Genmab's Epkinly Receives FDA Accelerated Approval for Follicular Lymphoma

by John Conrad| Jun 27, 2024| NewsBrief

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Epkinly (epcoritamab-bysp), a joint development by AbbVie and Genmab, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL). This approval specifically applies to patients who have received at least two lines of prior therapy.

Epkinly is the first and only subcutaneous T-cell engaging bispecific antibody approved for R/R FL. It's already approved in the U.S. for certain cases of diffuse large B-cell lymphoma (DLBCL) and is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20-positive cells.

Follicular lymphoma, the second most common form of non-Hodgkin lymphoma, affects approximately 15,000 new patients annually in the U.S. It's considered incurable, with frequent relapses and worsening prognosis after each relapse.

The FDA's decision was based on the phase 1/2 EPCORE NHL-1 clinical trial, which evaluated Epkinly in over 120 adults with R/R FL. The trial showed an impressive overall response rate of 82%, with a complete response rate of 60% and a partial response rate of 22%. Notably, over half of responding patients remained responsive at a median follow-up of 14.8 months.

Mariana Cota Stirner, VP of Therapeutic Area Head for Haematology at AbbVie, highlighted the convenience of subcutaneous dosing and noted that Epkinly can be administered without mandatory hospitalization using a three-step-up dosing regimen.

AbbVie and Genmab share commercial responsibilities for Epkinly in the U.S. and Japan, while AbbVie is responsible for global commercialization elsewhere. This approval marks another milestone for Epkinly, which was recently recommended by the UK's National Institute for Health and Care Excellence (NICE) for treating certain DLBCL patients under the brand name Tepkinly.

The availability of Epkinly provides a new treatment option for R/R FL patients, particularly those who have exhausted other therapies. As research continues, it may offer hope to those facing this challenging form of lymphoma.

This article was originally published on iBIO NewsBrief. Gain a head start on your day with iBIO NewsBrief. Subscribe to receive top industry headlines delivered straight to your inbox.