Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) have jointly announced that the U.S. Food and Drug Administration (FDA) has given Priority Review status to their supplemental Biologics License Application (sBLA) for epcoritamab-bysp. This antibody is a bispecific one that engages T-cells and is administered subcutaneously. It's intended for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

The Priority Review designation is significant, signifying that if approved, this therapy could provide substantial improvements in safety or effectiveness compared to standard applications. This designation accelerates the review process to six months instead of the usual 10. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2024.

Genmab, highlighted the urgent need for new treatment options for patients with R/R follicular lymphoma, especially those who have relapsed following standard therapies and exhibit poor prognostic factors. The acceptance of the epcoritamab application for Priority Review represents an essential step toward potentially offering a new treatment option for these patients.

The sBLA is backed by data from the Phase 1/2 EPCORE™ NHL-1 clinical trial, which showed promising overall and complete response rates in patients with R/R FL treated with epcoritamab. These results were presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023. Epcoritamab had previously received Breakthrough Therapy Designation (BTD) from the FDA for the treatment of adult patients with R/R FL after two or more lines of systemic therapy.

Epcoritamab is a product of the collaboration between Genmab and AbbVie in the field of oncology. The companies will jointly manage commercial responsibilities in the U.S. and Japan, with AbbVie leading further global commercialization efforts.

The Phase 1/2 EPCORE™ NHL-1 Trial is an open-label, multi-center study designed to evaluate the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. The trial consists of three parts: a dose escalation part, an expansion part, and an optimization part.

FL is the second most common form of NHL, representing a significant portion of lymphoma cases worldwide. Despite being an indolent lymphoma, FL is considered incurable with conventional therapies, and patients often experience relapses, leading to shorter periods of remission and increased healthcare costs.

Epcoritamab, developed using Genmab's proprietary DuoBody® technology, is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells. While epcoritamab has received regulatory approval in certain lymphoma indications in several territories, its use in FL is not yet approved in any region.

Genmab and AbbVie are also exploring the potential of epcoritamab as a monotherapy and in combination therapy across various lines of therapy in hematologic malignancies through ongoing phase 3 clinical trials. These trials include investigations into epcoritamab's efficacy in patients with R/R diffuse large B-cell lymphoma (DLBCL) and newly diagnosed DLBCL or FL, among others.

 

Source: globenewswire.com

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