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FDA Approves Epinkly, the First Bispecific Antibody Targeting Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Treatment supported under agency’s accelerated approval program.

a close-up of red blood cells flowing through a vein, displaying the characteristic sickle shape Generative AI. Image Credit: Above Stock Images/catalin

Image Credit: Above Stock Images/catalin

Abbvie, a pharmaceutical organization, and Genmab, a biotech company, have announced the FDA approval of Epinkly, the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Approved under the FDA’s accelerated approval program, this medication is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

"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, MD, 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."

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