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The FDA Grants Priority Review for Potential New Follicular Lymphoma Treatment, Epcoritamab, by Genmab A/S and AbbVie

Genmab A/S (NASDAQ: GMAB) and AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for epcoritamab, a promising candidate for patients with relapsed or refractory follicular lymphoma. This designation accelerates the therapy’s approval process, with a target action date set for June 28, 2024.

Epcoritamab, a T-cell engaging bispecific antibody, is designed to target and eliminate B cells in adult patients who have not responded to at least two lines of systemic therapy. The FDA’s Priority Review status is reserved for treatments offering significant improvements in safety or effectiveness for serious conditions compared to current standards. This status shortens the FDA review period to six months, rather than the standard 10 months.

The supplemental Biologics License Application (sBLA) for epcoritamab is supported by promising results from the Phase 1/2 EPCORE™ NHL-1 clinical trial, demonstrating favorable overall and complete response rates in patients with relapsed or refractory follicular lymphoma. These findings were presented at the American Society of Hematology’s Annual Meeting in December 2023.

Despite advancements in treatment, there remains a critical need for new options, particularly for patients with poor prognostic factors. Jan van de Winkel, Ph.D., CEO of Genmab, reaffirmed the company’s dedication to collaboration with the FDA and highlighted the milestone in potentially offering a new treatment for this patient population.

Epcoritamab is part of a strategic oncology collaboration between Genmab and AbbVie, with both companies sharing commercial responsibilities in the U.S. and Japan, while AbbVie will manage further global commercialization.

Follicular lymphoma, the second most common type of non-Hodgkin’s lymphoma, poses a significant challenge in the western world. Despite its slow-growing nature, it remains incurable with conventional therapy, often leading to relapse after remission and subsequent healthcare challenges. Genmab, renowned for its innovative antibody therapeutics, continues to leverage its proprietary technology platforms to address critical unmet needs in cancer and other severe diseases.