FDA Accepts for Priority Review BLA for Epcoritamab

The FDA has accepted for priority review AbbVie’s biologics license application for epcoritamab to treat adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The Prescription Drug User Fee Act (PDUFA) date is May 21, 2023.

Epcoritamab is an investigational subcutaneous bispecific antibody being co-developed by AbbVie and Genmab. It was created using Genmab’s DuoBody technology, which is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells. CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies.

The application is supported by results from the large B-cell lymphoma cohort of the EPCORE phase 1/2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma.

Catherine Thieblemont

“Large B-cell lymphoma is a fast-growing, difficult to treat type of aggressive non-Hodgkin's lymphoma,” Professor Catherine Thieblemont, head of the Hemato-Oncology Department at Hôpital Saint-Louis, Paris, France, said in a press release when results were released in June 2022. “Some treatment approaches like chemotherapy and immunotherapy have been in place for decades and newer treatments like CAR T-cell therapies involve multiple steps before a patient can begin treatment so there is still a need for additional treatment options.”

The study cohort, which included 157 relapsed/refractory LBCL patients, demonstrated an overall response rate (ORR) of 63% and a complete response (CR) rate of 39%. Patients enrolled in the study who were naïve to CAR T-cell therapy achieved a 69% overall response rate and a 42% complete response, and patients who received prior CAR T-cell therapy achieved a 54% overall response rate and a 34% complete response. After a median follow up of 10.7 months, the median duration of response was estimated to be 12 months.

In October 2022, the European Medicines Agency validated for review a Marketing Authorization Application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory DLBCL after two or more lines of systemic therapy.