The US Food and Drug Administration (FDA) has accepted AbbVie’s Biologics License Application (BLA) of epcoritamab (DuoBody-CD3xCD20) to treat adults with relapsed/refractory (r/r) large B-cell lymphoma (LBCL), for priority review.
Epcoritamab is intended for usage in such patients following two or more lines of systemic therapy.
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The BLA is backed by data from the LBCL cohort of the open-label, multicentre Phase I/II EPCORE NHL-1 clinical trial of subcutaneous epcoritamab.
The trial analysed the safety and initial efficacy of the therapy in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including LBCL and diffuse large B-cell lymphoma (DLBCL).
An investigational IgG1-bispecific antibody, epcoritamab attaches to CD3 on T-cells and CD20 on B-cells at the same time to elicit T-cell-facilitated CD20+ cells’ destruction.
Under an oncology partnership, AbbVie and Genmab are jointly developing the therapy.
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By GlobalDataCommercial responsibilities in the US and Japan will be shared by the parties while AbbVie will oversee epcoritamab’s marketing globally.
Two Phase III trials are underway analysing epcoritamab as a single agent for r/r DLBCL as well as epcoritamab combination in r/r follicular lymphoma patients, respectively.
AbbVie global oncology development vice-president and head Mohamed Zaki said: “We are committed to the research and development of innovative therapies to provide important treatment options for people living with blood cancer such as large B-cell lymphoma, which has limited treatment options in the relapsed/refractory setting.
“This milestone signals an early step in our hope to develop a core therapy for people living with B-cell malignancies.”
In October this year, the European Medicines Agency validated the company’s Marketing Authorization Application for epcoritamab to treat relapsed/refractory (r/r) DLBCL in adults following two or more lines of systemic treatment.
