Genmab A/S and AbbVie have received Priority Review from the FDA for epcoritamab-bysp, a bispecific antibody for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This review status is granted to therapies with the potential to provide significant improvements over existing treatments for serious conditions and shortens the FDA review period to six months.
The FDA has set a target action date of June 28, 2024, for this application. The decision for Priority Review is grounded in the results from the Phase 1/2 EPCORE™ NHL-1 clinical trial, which demonstrated high overall and complete response rates in patients with R/R FL treated with epcoritamab. These promising data from the trial were presented at the ASH Annual Meeting and Exposition in December 2023.
Epcoritamab has previously received Breakthrough Therapy Designation (BTD) by the FDA, including additional data from the dose optimization part of the EPCORE NHL-1 trial. This BTD underscores the FDA’s recognition of epcoritamab’s potential to offer a significant benefit over existing therapies for this patient population.
Epcoritamab is being co-developed by Genmab and AbbVie under an oncology collaboration, with shared commercial responsibilities in the U.S. and Japan and AbbVie handling global commercialization. The EPCORE™ NHL-1 trial is examining epcoritamab’s safety and efficacy in patients with various types of relapsed, progressive, or refractory B-cell non-Hodgkin’s lymphomas (B-NHLs), including FL, who have limited treatment options.
With the FDA’s Priority Review, Genmab and AbbVie are one step closer to bringing this new treatment to patients affected by R/R FL, potentially transforming the therapeutic landscape for this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
