License submitted to FDA for drug to help those with large B-cell lymphoma

A biologics license application has been submitted to the US Food and Drug Administration (FDA) for an antibody to treat patients with B-cell lymphoma.

Genmab A/S is a biotechnology company that says its core purpose is to improve the lives of people with cancer. Recently it announced its intent to submit the application for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for those with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of this year (2022).

Oncology collaboration

Epcoritamab is being co-developed by Genmab and AbbVie, a biopharma company that develops and delivers new medicines, as part of their oncology collaboration.

It is an investigational immunoglobulin 1 (the most abundant IgG subclass in human sera and is important for mediating antibody responses against viral pathogens) bispecific antibody created using Genmab’s proprietary DuoBody technology. The technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types.

The submission is supported by results from the large b-cell lymphoma (LBCL) cohort of a trial called the EPCORE NHL-1 open-label,

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