Genmab submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its experimental large B-cell lymphoma drug DuoBody®-CD3xCD20 (subcutaneous epcoritamab), according to a press release from the company.

Moreover, the company also announced that AbbVie submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

“Even with existing therapies to treat these lymphomas, there is a significant medical need for alternative and accessible treatment options for patients who are unable to tolerate current treatments or whose treatments have failed,” said Jan van de Winkel, PhD, the chief executive officer of Genmab, in a press release.

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“Together with our partner AbbVie, we believe epcoritamab has the potential to become a core therapy for patients with B-cell malignancies, and the submission of these regulatory applications to the FDA and EMA is an important step in potentially bringing epcoritamab to people living with relapsed/refractory B-cell lymphomas,” van de Winkel continued.

The submissions are supported by results obtained in an open-label, multicenter phase 2 clinical trial evaluating the safety and efficacy of epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin lymphoma, including DLBCL.

Epcoritamab is an IgG1-bispecific antibody developed using Genmab’s proprietary DuoBody® technology that is designed to direct cytotoxic T cells selectively to mount an immune response against target cell types. The experimental treatment is designed to bind to CD3 on T cells and CD20 on B cells at the same time, thereby inducing the T cell-mediated killing of CD20+ B cells.

Genmab and AbbVie are collaborating to develop the treatment. In the US and Japan, commercial responsibilities will be shared between the 2 companies, while further global commercialization will be realized by AbbVie.  

Reference

Genmab announces submissions of regulatory applications for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma (LBCL) and diffuse large B-cell lymphoma (DLBCL). News release. Genmab; October 28, 2022.