Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY/TEPKINLY) for the Treatment of Relapsed/Refractory Follicular Lymphoma

Genmab A/S (Nasdaq: GMAB) today announced regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. BTD may expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.

Additionally, the EMA has validated a Type II variation application for epcoritamab for the same indication. EMA validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.

“Despite recent treatment advances in relapsed or refractory follicular lymphoma, a need still exists for more treatment options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We are encouraged by these recent decisions from the regulatory authorities, and we are hopeful that this may help accelerate the process of delivering epcoritamab to people living with this disease. We’re committed to working with AbbVie to explore the full potential of epcoritamab as a potential core therapy for patients with B-cell malignancies.”

These regulatory actions were supported by previously announced results from the phase 1/2 EPCORE NHL-1 clinical trial, an open-label, multi-center safety and preliminary efficacy study evaluating subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including FL. Updated results from the R/R FL cohort of the EPCORE NHL-1 trial, including an optimized dosing schedule allowing for outpatient administration, will be presented at the upcoming 65^th Annual Meeting and Exposition of the American Society of Hematology (ASH) taking place December 9-12 in San Diego, California.