NICE issues Final Draft Guidance recommending IMBRUVICA^® (ibrutinib) with R-CHOP for untreated mantle cell lymphoma when a stem cell transplant is suitable

Mantle cell lymphoma is a rare, usually aggressive type of non-Hodgkin lymphoma that affects around 600 people in the UK each year.¹

NICE’s final draft guidance (FDG) is based on Phase 3 investigator-initiated TRIANGLE study demonstrated improved failure-free survival, progression-free survival and overall survival for an ibrutinib-based regimen compared with standard care involving autologous stem cell transplant (ASCT).²

With this positive FDG, ibrutinib becomes the first alternative therapy for this patient population, who have only had the option of first-line treatment with ASCT and chemo-immunotherapy until now.²

High Wycombe, UK (04 September 2026) – Johnson & Johnson is pleased that the National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance recommending IMBRUVICA^® (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP), alternating with rituximab, dexamethasone, cytarabine and cisplatin (R-DHAP) or oxaliplatin (R-DHAOx), both without ibrutinib, followed by ibrutinib monotherapy, for adults with previously untreated mantle cell lymphoma (MCL) who are suitable for an autologous stem cell transplant (ASCT).² This draft guidance represents a pivotal step in moving beyond transplant as the first-line standard of care for those with MCL, and means eligible patients can soon access an ibrutinib-based first-line treatment regimen on the NHS in England, Wales and Northern Ireland.²

Unmet treatment need for MCL patients

MCL is a type of non-Hodgkin lymphoma that originates from B cells,¹ which are a functional component of the human immune system. The abnormal B cells usually develop in a part of the lymph nodes called the ‘mantle zone’ and typically grow quickly.¹ Approximately 600 people are diagnosed in the UK each year, with the majority being diagnosed at an advanced stage.¹ MCL is a relapsing-remitting condition that is generally considered incurable.¹

For people who are suitable for ASCT, current treatment typically involves intensive chemo-immunotherapy followed by a transplant and maintenance therapy, which is administered in hospital over several days.² The TRIANGLE study demonstrates ibrutinib’s potential to replace or compliment a transplant-based regimen, offering eligible patients a more effective path to long term remission and representing the first major step forward in first-line mantle cell lymphoma treatment in years.²

The NICE committee agreed that ibrutinib is expected to be significantly less resource-intensive than the current standard of care, potentially freeing up NHS capacity and reducing the logistical burden on patients.²

TRIANGLE clinical trial data

NICE’s positive FDG of ibrutinib with R-CHOP is based on data from TRIANGLE, an open-label Phase 3, randomised controlled trial.¹ It compared ibrutinib plus R-CHOP alternating with R-DHAP or R-DHAOx, both without ibrutinib, followed by ibrutinib maintenance with optional rituximab (n=268), and standard care, which was rituximab-based induction followed by high-dose therapy and ASCT consolidation, with optional rituximab maintenance (n=269).³ Ibrutinib nominally significantly improved failure-free survival compared with ASCT (hazard ratio 0.64, 95% confidence interval [CI] 0.43 to 0.95, p=0.0068) and nominally significantly improved progression-free survival (hazard ratio 0.63, 95% CI 0.42 to 0.95, p=0.0060) and overall survival (hazard ratio 0.52, 95% CI 0.34 to 0.80, p=0.0023).³ The absolute number of adverse events was similar between treatment arms, but that the duration of treatment exposure was significantly longer in the ibrutinib arm.^2,3 Treatment discontinuation due to adverse reactions was observed in 13% in the ibrutinib arm.²

Expert and company perspectives on the NICE recommendation

“We welcome the approval of ibrutinib in combination with chemo-immunotherapy as an important treatment option for people with mantle cell lymphoma”, said Anna Grint, Patient and Public Affairs at Lymphoma Action. “Throughout the NICE appraisal, we worked closely with people affected by mantle cell lymphoma to ensure that their experiences and priorities were heard. For many patients, the prospect of a stem cell transplant can be one of the most challenging aspects of treatment. Having access to an effective alternative that may potentially eliminate the need for a transplant means fewer side effects, a faster recovery, and less disruption to daily life. This decision represents a significant step forward and gives people affected by mantle cell lymphoma greater choice in their treatment.”

“The approval of the targeted therapy ibrutinib in combination with chemo-immunotherapy is fantastic news for patients with untreated mantle cell lymphoma as it is an effective option that prolongs survival and alleviates the toxicity associated with an autologous stem cell transplant (ASCT)”, said Dr. David Lewis, Consultant Haematologist, University Hospitals Plymouth NHS Trust. “It will also allow more outpatient-based treatment and mean less time in hospital for patients who would otherwise have had an ASCT.”

“We are delighted that NICE has recommended this ibrutinib-based regimen for eligible people living with mantle cell lymphoma,” said Amanda Cunnington, UK Senior Director, Patient Access, Johnson & Johnson. “The aggressive nature of this type of blood cancer can be devastating for patients and their loved ones, and it’s vital that they have as many transplant-free treatment options available to them as possible. At Johnson & Johnson, we remain committed to working in partnership with the NHS, healthcare professionals and the patient community to help improve outcomes for people affected by blood cancers and would like to thank everyone involved in the appraisal process for helping to bring about this important milestone.”

#ENDS#

About the TRIANGLE study
TRIANGLE was a Phase 3 open-label, randomised, controlled clinical trial that was initiated by investigators and conducted across 165 sites in 13 European countries.^2,3 It compared ibrutinib plus R-CHOP alternating with R-DHAP or R-DHAOx, both without ibrutinib, followed by ibrutinib maintenance with optional rituximab (n=268), and standard care, which was rituximab-based induction followed by high-dose therapy and ASCT consolidation, with optional rituximab maintenance (n=269).² The primary endpoint was failure-free survival (FFS), defined as the time from randomisation to stable disease at the end of induction treatment, progressive disease or death from any cause.² FFS is an extension of progression-free survival (PFS) because it adds a response element; cancer that did not have a complete or partial response at the end of induction treatment was counted as a treatment failure, even if it was stable.² Other endpoints included overall survival (OS), overall response rate (ORR) and complete response (CR) rate.³

Ibrutinib nominally significantly improved FFS compared with ASCT (hazard ratio 0.64, 95% CI 0.43 to 0.95, p=0.0068) and nominally significantly improved PFS (hazard ratio 0.63, 95% CI 0.42 to 0.95, p=0.0060) and OS (hazard ratio 0.52, 95% CI 0.34 to 0.80, p=0.0023).³ ORR was 96.3% (95% CI 93.3% to 98.2%) with ibrutinib versus 92.2% (95% CI 88.3% to 95.1%) with ASCT, and CR rates were 67.2% (95% CI 61.2% to 72.8%) versus 64.7% (95% CI 58.7% to 70.4%), respectively.³

The absolute number of adverse events was similar between treatment arms, but the duration of treatment exposure was significantly longer in the ibrutinib arm (28.5 months).^2,3 Among patients receiving ibrutinib, the most common Grade ≥3 adverse events were thrombocytopenia (61%), neutropenia (60%), febrile neutropenia (14%) and pneumonia (9%).³ Treatment discontinuation due to adverse events was observed in 13% in the ibrutinib arm, while adverse events leading to dose reduction occurred in approximately 12% of patients receiving ibrutinib.³

About ibrutinib
Ibrutinib is a type of therapy called a tyrosine kinase inhibitor (TKI).² By blocking Bruton’s tyrosine kinase (BTK), which is needed by cancer cells to multiply and spread, ibrutinib may help move abnormal cells out of their nourishing environments to stop them from growing and dividing.^4,5

Ibrutinib is indicated:
· in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) alternating with R-DHAP or R-DHAOx without ibrutinib, followed by ibrutinib monotherapy, for the treatment of adult patients with previously untreated MCL who would be eligible for ASCT
· as a single agent for the treatment of adult patients with relapsed or refractory MCL
· as a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
· as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
· as a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. Ibrutinib in combination with rituximab is indicated for the treatment of adult patients with WM.³

About mantle cell lymphoma¹
MCL is a rare and usually aggressive type of non-Hodgkin lymphoma that originates from B-cells. The abnormal B-cells usually develop in a part of the lymph nodes called the mantle zone. In around 1 in 10 people, MCL grows slowly and causes few or no symptoms, but in most cases, it is fast-growing and requires treatment straightaway. Approximately 600 people are diagnosed with MCL in the UK each year, with most people being middle-aged or older. It is most commonly diagnosed at an advanced stage and is considered incurable, meaning it nearly always comes back. What causes MCL isn’t yet known, and the most common symptom is swollen lymph nodes in several parts of the body (which manifest as lumps). Other symptoms can include feeling full quickly when eating, pain or discomfort behind the ribs, tiredness, shortness of breath, unexplained bruising or bleeding and frequent infections.

About Johnson & Johnson
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Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to ibrutinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

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*Lymphoma Action spokesperson and Dr. David Lewis have not been paid for any media work.