Pharma Focus Asia

AbbVie Announces U.S. FDA Approval of EPKINLY™ (epcoritamab-bysp)

Friday, May 19, 2023

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only bispecific antibody to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The 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, 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.

EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more treatments for their cancer. 

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.
 

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