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AbbVie, Genmab File for Bispecific Antibody Approval in US, EU for CD20-Positive Advanced Lymphoma

NEW YORK – AbbVie and Genmab on Friday announced two regulatory submissions for its bispecific antibody DuoBody CD3xCD20 (epcoritamab) for certain advanced lymphoma patients.

AbbVie and Genmab — which are codeveloping the agent as part of an ongoing oncology collaboration — have applied for DuoBody CD3xCD20 approval in both Europe and the US. Specifically, AbbVie submitted an application to the European Medicines Agency for the drug as a treatment for relapsed or refractory diffuse large B-cell lymphoma patients after two or more lines of systemic therapy, and Genmab submitted a biologics license application to the US Food and Drug Administration for the drug as a treatment for relapsed or refractory large B-cell lymphoma after two or more lines of therapy.

Both applications include data from the LBCL cohort of the EPCORE NHL-1 trial, in which patients with CD20-positive B-cell non-Hodgkin lymphoma, including DLBCL, received DuoBody CD3xCD20. The agent is designed to bind to CD3 on patients' T cells and CD20 on their B cells, in turn causing the T cells to attack CD20-positive B cells.

AbbVie and Genmab equally share commercial responsibilities for DuoBody CD3xCD20 in the US and Japan, while AbbVie holds the rights to commercialize the agent elsewhere in the world. The firms are also evaluating the agent in a Phase III randomized trial as a monotherapy versus chemotherapy for CD20-positive relapsed or refractory DLBCL.