COPENHAGEN - The U.S. Food and Drug Administration (FDA) has granted Priority Review for epcoritamab, a potential new treatment for patients with relapsed or refractory follicular lymphoma, announced Genmab A/S (NASDAQ: NASDAQ:GMAB) and AbbVie (NYSE: NYSE:ABBV). This designation could significantly expedite 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 awarded to treatments that may offer considerable improvements in safety or effectiveness for serious conditions compared to current standard options. 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 results from the Phase 1/2 EPCORE™ NHL-1 clinical trial, which showed promising 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 pressing need for new options for this patient group, particularly those with poor prognostic factors. Jan van de Winkel, Ph.D., CEO of Genmab, expressed the company's commitment to working with the FDA and highlighted the milestone in potentially offering a new treatment for these patients.
Epcoritamab is part of a strategic oncology collaboration between Genmab and AbbVie. The two companies will share commercial responsibilities in the U.S. and Japan, with AbbVie handling further global commercialization.
Follicular lymphoma is the second most common type of non-Hodgkin's lymphoma, representing a significant portion of lymphomas in the western world. It is typically slow-growing but considered incurable with conventional therapy. Patients often relapse after achieving remission, leading to increased healthcare costs and reduced quality of life.
Genmab, a biotechnology company, specializes in creating innovative antibody therapeutics. The company's proprietary technology platforms have led to a pipeline of potential treatments for cancer and other serious diseases.
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