COPENHAGEN, Denmark; November 21, 2022
Epcoritamab BLA accepted for FDA Priority review; FDA action date is May 21, 2023Epcoritamab could become the first subcutaneous bispecific antibody approved for the treatment of LBCLBLA submission supported by positive EPCORE™ NHL-1 trial results
Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 21, 2023.
The BLA submission is based on safety and preliminary efficacy data from the LBCL cohort of the pivotal EPCORE™ NHL-1 open-label, multi-center phase 2 clinical trial evaluating epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL). These results were presented in a late-breaking oral presentation as a part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022), in Vienna, Austria.
“We are pleased that the BLA for epcoritamab has been accepted for Priority Review by the FDA, accelerating the pathway for approval and bringing us one step closer to potentially delivering a novel treatment option to relapsed and refractory LBCL patients who are in need of additional treatment options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Together with our partner, AbbVie, we recognize the unmet need for safe, effective and accessible treatments for patients with B-cell malignancies and we believe that epcoritamab has the potential to become a core therapy in this patient population.”
Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share