FDA accepts for priority review the supplemental BLA for epcoritamab (Epkinly) for difficult-to-treat relapsed or refractory follicular lymphoma

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. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2024.

“While treatment for patients with relapsed and refractory follicular lymphoma has progressed, there remains an urgent need for new treatment options, particularly for patients who are considered difficult to treat due to relapse following standard therapies and other poor prognostic factors,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The acceptance of the epcoritamab application for Priority Review marks an important milestone toward potentially providing a new treatment option to patients affected by R/R follicular lymphoma. Together with AbbVie, we look forward to working with the FDA during the review and remain committed to developing epcoritamab as a potential future core therapy for B-cell malignancies.”

The sBLA is based on results from the Phase 1/II 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. About the Phase 1/II EPCORE™ NHL-1 Trial.