The MHRA has granted conditional marketing authorisation for Tepkinly (epcoritamab) as a bispecific treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
The conditional marketing authorisation for Great Britain is based on the single-arm Phase I/II EPCORE NHL-1 trial data, which demonstrated a 62% (86/139) overall response rate and 39% (54/139) complete response rate in patients.
Epcoritamab is the first licensed subcutaneous bispecific treatment option for R/R DLBCL in Great Britain. In contrast to existing therapeutic options, epcoritamab does not require cell collection and engineering.
It was recommended for approval by the EU Committee for Medicinal Products for Human Use (CHMP) in July 2023.
“Despite recent therapeutic advances, treatment options for patients with R/R DLBCL after two previous therapies are limited. For such patients living with this type of aggressive blood cancer, many experience disease progression and have poor prognosis,” said Professor Chris Fox, Professor of Haematology, School of Medicine, University of Nottingham and Honorary Consultant Haematologist, Nottingham University Hospitals NHS Trust. “As a novel bispecific antibody, given as a subcutaneous injection, epcoritamab offers a new treatment option for this difficult-to-treat patient group.”
Epcoritamab is a bispecific antibody designed to simultaneously bind to two proteins, cluster of differentiation (CD)3 on T cells in the immune system and CD20 on cancerous B cells, in order to induce T-cell mediated killing of cancerous B cells.
“Today’s news is an important step forward in enabling us to provide this hard-to-treat patient group with an innovative subcutaneous treatment option,” said Belinda Byrne, Medical Director, AbbVie UK. “We are working with the NHS and relevant authorities to bring access to eligible patients and clinicians throughout the UK as quickly as possible.”