EPKINLY™ approved by U.S. FDA as the first bispecific antibody to treat adults with relapsed or refractory diffuse large B-Cell Lymphoma (DLBCL)

AbbVie announces approval of EPKINLYTM (epcoritamab-bysp) by the Food and Drug Administration (FDA) as the first T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies. EPKINLY is approved under the FDA’s Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

DLBCL is a type of aggressive, fast-growing non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL, comprising of an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally. DLBCL patients are typically treated with chemoimmunotherapy-based regimens. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, single agent and ready-available or off-the-shelf treatment options are limited.1,2,3,4,5

“DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances.”

AbbVie is committed to transforming standards of care across blood cancers and advancing a dynamic cancer research and treatment pipeline. EPKINLY marks the third approved blood cancer treatment available as part of AbbVie’s growing oncology portfolio, as we strive to make a remarkable impact for people living with cancer.

“Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging,” said Tycel Phillips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. “Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies.”

“The FDA approval of EPKINLY represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.

Highlights of the Phase 1/2 EPCORE™ NHL-1 clinical trial supporting the approval:

  • In the expansion cohort of the EPCORE NHL-1 trial, 148 patients with CD20+ DLBCL were enrolled, 86 percent of which were diagnosed with DLBCL NOS, including 27 percent with DLBCL transformed from indolent lymphoma, and 14 percent with HGBL. The median number of prior therapies was three (range: 2 to 11), with 30 percent receiving two prior therapies, 30 percent receiving three prior therapies, and 40 percent receiving four or more prior therapies. Eighteen percent had prior autologous hematopoietic stem cell transplantation (HSCT), and 39 percent had prior chimeric antigen receptor (CAR)T-cell therapy. Eighty-two percent of patients had disease refractory to last therapy and 29 percent of patients were refractory to CAR T-cell therapy.
  • EPKINLY delivered an overall response rate of 61 percenta complete response rate of 38 percent and median duration of response of 15.6 months in heavily pretreated R/R DLBCL patients.
  • The prescribing information has a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections, cytopenias, and embryo-fetal toxicity. The most common (≥ 20 percent) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Please see additional Important Safety Information, below.


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