Approvals
AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended Tepkinly (epcoritamab) as a treatment option for adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or not responded to two previous treatments.
This recommendation follows data from the singlearm phase 1/2 EPCORE NHL-1 trial, which displayed a 62% overall response rate, meaning 62% of patients’ blood cancer was either reduced by half (partial response) or showed no evidence of disease from tests and scans (complete response). Complete response rate was 39%.
Rincy George, policy officer at Blood Cancer UK, commented: “Diffuse large B-cell lymphoma is a type of blood cancer and, while most people go into remission after standard treatment, some people can see their cancer return. Like many that experience blood cancer, people with relapsed or refractory (R/R) DLBCL experience anxiety around the prospect of not responding to treatment or the cancer once again returning. Epcoritamab (Tepkinly), is an injectable bispecific antibody designed to recognise and attach to the cancer cells and immune cells, so that the body’s immune system can destroy them. Today’s decision from NICE approving epcoritamab for eligible patients for use on the NHS in England and Wales is a welcome step for many.”
BelindaByrne,medicaldirectoratAbbVieUK,added: “AbbVie is committed to advancing care for people living with blood cancer. We are delighted that NICE has recognised the benefit that epcoritamab can have on the lives of people living with R/R DLBCL. We will continue working closely with the relevant authorities to provide equitable access across the UK for eligible R/R DLBCL patients in need.”
Professor Chris Fox, professor of Haematology, School of Medicine, University of Nottingham and Honorary Consultant Haematologist, Nottingham University Hospitals NHS Trust, stated: “Despite recent therapeutic advances, treatment options for this hard-to-treat group of patients have been limited. This can mean many patients do not have suitably effective treatment options, resulting in a poor prognosis. Today’s decision by NICE on epcoritamab provides physicians with a second bispecific antibody as a treatment option for eligible patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of therapy. Epcoritamab is the first bispecific to be given as a subcutaneous injection, which gives patients and clinicians an additional choice of administration option, which may help to support capacity planning within lymphoma services. The decision by NICE will be welcomed by both patients and the clinical community.”