Genmab A/S and AbbVie announced the U.S. Food and Drug Administration (FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The FDA grants Priority Review to investigational therapies that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. This designation shortens the review period to six months compared to 10 months for Standard Review.i The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2024.

The sBLA is based on results from the Phase 1/2 EPCORE? NHL-1 clinical trial, which demonstrated high overall and complete responses in patients with R/R FL treated with epcoritamab. Data from the FL cohort of the trial were presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023.

The FDA previously granted Breakthrough Therapy Designation (BTD) to epcoritamab for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. The application for BTD included additional data from the dose optimization part of EPCORE NHL-1. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.