NICE Recommends TEPKINLY®▼ (epcoritamab), a Subcutaneous Bispecific Antibody for Adults With Relapsed/Refractory (R/R) Follicular Lymphoma (FL) After Two or More Lines of Systemic Therapy

NICE Recommends TEPKINLY®▼ (epcoritamab), a Subcutaneous Bispecific Antibody for Adults With Relapsed/Refractory (R/R) Follicular Lymphoma (FL) After Two or More Lines of Systemic Therapy

• Epcoritamab can now be accessed as an option to treat relapsed or refractory follicular lymphoma in adults after 2 or more lines of systemic treatment, only if epcoritamab is stopped after 3 years of treatment or earlier if the lymphoma progresses.1
• The NICE recommendation is based on the single-arm Phase 1/2 EPCORE NHL-1 trial, where epcoritamab demonstrated responses in people whose cancer has returned or has not responded to at least two treatments.2
• Follicular lymphoma is an incurable blood cancer that affects around 2,300 people in the UK every year, it is a challenging form of cancer to treat, especially in later lines of therapy where there is no standard approach.3,4

MAIDENHEAD, UK, 23 February 2026 – AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has recommended Tepkinly® (epcoritamab) as an option within the NHS to treat adults with follicular lymphoma (FL) whose cancer has returned (relapsed) or not responded to at least two prior treatments (refractory) only if epcoritamab is stopped after 3 years of treatment or earlier if the lymphoma progresses. Epcoritamab is the first bispecific antibody recommended by NICE for people living with FL, offering an additional option for those in third or later lines of treatment where there is currently no standard approach.

The NICE recommendation is based on results from the Phase 2 cohort of the single-arm study (EPCORE NHL-1) of epcoritamab monotherapy in 128 adults with relapsed or refractory FL who had received at least two prior systemic treatments. The study reported an 82% (n=105/128) overall response rate, meaning 82% of participants’ blood cancer reduced by at least half (partial response) or showed no evidence of disease from tests and scans (a complete response).2 The complete response rate was 62.5% (n=80/128), meaning there was no evidence of disease from tests and scans in 62.5% of FL patients.2

Follicular lymphoma is the most common form of low-grade non-Hodgkin's lymphoma (NHL), affecting 20% of people with NHL in the UK.3 It is slow growing and incurable, meaning most people with the disease will require ongoing treatment and lifelong monitoring.5,6 In early stages, patients may experience long periods of remission, where signs of disease are minimal or undetectable. However, patients often relapse, and each time the cancer returns, the periods of remission become shorter.6.7

“For people with follicular lymphoma, NICE’s positive recommendation of epcoritamab means that there is now another therapy available for when their lymphoma hasn’t responded to at least two treatments and their options have become increasingly limited,” said Ropinder Gill, Chief Executive at Lymphoma Action.

“We know from talking to people with follicular lymphoma just how deeply each relapse impacts both emotional wellbeing and physical health, causing growing anxiety and uncertainty. We very much welcome this decision as it addresses an urgent need for those who face the challenge of having limited treatments available to them”.

Epcoritamab is part of a class of therapies called bispecific antibodies, that help the body’s immune system to attack and destroy cancerous cells.8 Epcoritamab is designed to simultaneously attach to two different cells, one immune T cell and one cancerous lymphoma cell, bringing them together, so the immune T cell is activated to destroy the cancerous lymphoma cell.8

Kim Linton, Professor of Medical Oncology at the University of Manchester and Honorary Consultant at The Christie NHS Foundation Trust, commented: “NICE’s recommendation of epcoritamab marks a significant milestone for patients and clinicians, addressing a critical gap in care for people with relapsed or refractory follicular lymphoma. As the first NICE recommended bispecific antibody therapy for this condition, epcoritamab offers an additional mechanism of action and a subcutaneous mode of administration, expanding the therapeutic landscape for an underserved population.”

Dr. Rachael Millward, Medical Director, AbbVie UK said: “At AbbVie, we are committed to transforming standards of care for people living with blood cancers, including follicular lymphoma. NICE’s positive recommendation marks a crucial milestone for patients with relapsed or refractory follicular lymphoma who have exhausted existing treatment options. Together with our partner Genmab, we are proud of this important step forward, reflecting our dedication to improving outcomes for people affected by blood cancer.”

References

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1 NICE. Epcoritamab for treating relapsed or refractory follicular lymphoma after 2 or more systemic treatments [ID6338]. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta11385. [Last accessed: February 2026].

2 Linton KM, Vitolo U, Jurczak W, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024;11(8): e593-e605.

3 Cancer Research UK. Follicular lymphoma. Available from: https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/follicular-lymphoma#:~:text=How%20common%20is%20it?,more%20painless%20swellings%20in%20the: [Last accessed: February 2026].

4 Skarbnik AZ, Patel K. Treatment selection for patients with relapsed or refractory follicular lymphoma. Front Oncol. 2023;13:1120358. doi:10.3389/fonc.2023.1120358.

5 Lymphoma Action. Active monitoring (watch and wait). Available from: https://lymphoma-action.org.uk/about-lymphoma-lymphoma-treatment/active-monitoring-watch-and-wait [Last accessed: February 2026].

6 Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.

7 Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.