FDA Prioritizes Review of EPKINLY® for Tough Follicular Lymphoma Cases

AbbVie (NYSE: ABBV) announces today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) concerning epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody. This treatment targets adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after undergoing two or more lines of therapy. If approved, epcoritamab-bysp (EPKINLY®) will be the premier subcutaneous bispecific antibody designated for adults with R/R FL after two prior therapy lines, adding to its current indication for R/R third-line diffuse large B-cell lymphoma (DLBCL) treatment, which gained FDA and European Medicines Agency (EMA) approval.

Priority Review status is granted to investigational therapies that present potential significant improvements in safety or effectiveness compared to standard applications. This designation accelerates the review period to six months, as opposed to the standard 10 months. Furthermore, the investigational R/R FL indication received Breakthrough Therapy Designation from the FDA and was submitted to the EMA in November 2023.

Mariana Cota Stirner, M.D., Ph.D., Vice President and Therapeutic Area Head for Hematology at AbbVie, highlighted the persistent challenges in treating follicular lymphoma, emphasizing the need for additional treatment options due to common relapses. Stirner expressed commitment to advancing epcoritamab in collaboration with partner Genmab as a fundamental therapy for lymphoma.

The sBLA draws upon data from the Phase 1/2 EPCORE™ NHL-1 clinical trial, demonstrating notable overall and complete responses among patients with R/R FL who underwent two or more lines of therapy with epcoritamab. Findings from the FL cohorts of this trial were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023. Notably, an optimization cohort explored alternative step-up dosing to minimize the risk and severity of cytokine release syndrome (CRS) and facilitate potential outpatient administration.

Epcoritamab is a collaborative development effort between AbbVie and Genmab under their oncology partnership. Commercial responsibilities in the U.S. and Japan will be shared between the companies, with AbbVie overseeing global commercialization. Both entities will pursue further international regulatory approvals for the investigational R/R FL indication, along with additional approvals for the R/R DLBCL indication.

The Phase 1/2 EPCORE™ NHL-1 Trial evaluates epcoritamab’s safety and preliminary efficacy across three parts: dose escalation, expansion, and optimization. The trial aims to assess subcutaneous epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including FL after two or more lines of systemic therapy.

FL, the second most common form of NHL, presents as an indolent lymphoma with limited therapeutic options. Despite advancements, FL remains incurable with conventional therapy, often leading to relapse and shorter remission periods with each recurrence.

Epcoritamab, created using Genmab’s proprietary DuoBody® technology, is an investigational IgG1-bispecific antibody administered subcutaneously. It is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, eliciting a T-cell-mediated killing response against CD20+ cells.

EPKINLY® (epcoritamab-bysp) U.S. prescribing information includes important safety information highlighting potential serious side effects, including CRS and neurologic problems. Monitoring for symptoms during treatment is crucial, with potential temporary or permanent treatment discontinuation if certain side effects arise.

AbbVie’s commitment in oncology extends to transforming standards of care for various blood cancers. With over 20 investigational medicines across 300 clinical trials, AbbVie aims to deliver breakthrough therapies while addressing patient access challenges.

For more information on AbbVie’s efforts in oncology, visit http://www.abbvie.com/oncology.

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