NICE gives green light to ibrutinib plus venetoclax as first-line treatment option for chronic lymphocytic leukaemia

High Wycombe, 21 April 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended Imbruvica^® (ibrutinib) plus venetoclax as an option for untreated chronic lymphocytic leukaemia (CLL) in adults.[1]

CLL is an incurable blood cancer which affects white blood cells and bone marrow.[2] It’s the most common type of leukaemia in adults, with around 3,800 people diagnosed in the UK each year.[2],[3] CLL patients may live with a considerable burden of symptoms which have a debilitating effect on their quality of life.[1] It’s therefore important for patients to be able to access a range of effective and well-tolerated treatment options.

Hilary Lindsay, Chair of CLL Support said: "We are very pleased that the combination of ibrutinib and venetoclax has been approved by NICE for previously untreated CLL patients. We believe this is a great step forward in the treatment of CLL and will, we are sure, prove to be of huge benefit to patients."

Amanda Cunnington, Director of Patient Access, Janssen-Cilag Limited said: “We are delighted with NICE’s decision to recommend ibrutinib plus venetoclax, especially since it has been recommended for use in the entire indicated population in England. The availability of this combination therapy will bring a much-needed new treatment option for those living with CLL, and Janssen is proud to have added to our existing ibrutinib-based treatment options for patients across England and Wales. We look forward to seeing eligible patients benefit from this treatment, and remain committed to advancing innovations in blood cancer across the world.”

#ENDS#

About ibrutinib

Ibrutinib is a type of therapy called a tyrosine kinase inhibitor (TKI).[4] 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]

Imbruvica^® is indicated in Great Britain as:[6]

• a single agent for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
• a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated CLL
• 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
• 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. Imbruvica^® in combination with rituximab is indicated for the treatment of adult patients with WM.

Important safety information

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib, please refer to the Summary of Product Characteristics for further information.

About CLL

CLL is a blood cancer which affects white blood cells and bone marrow.[3] It is the most common type of leukaemia in adults, with around 3,800 people in the UK diagnosed with CLL each year.[3] Most CLL patients do not have any symptoms on diagnosis, but the most common symptoms to develop as the disease progresses are night sweats, fevers and chills, unexplained weight loss and general fatigue.[2] Other symptoms include bone pain, easy bruising and bleeding, swelling of lymph nodes under the arms, neck or groin, swelling of the abdomen and frequent infections.[2]

While patient outcomes have dramatically improved in the last few decades, CLL is ultimately incurable, meaning most patients will relapse after therapy.[7],[8] Therefore, patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.[7]

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism, & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Learn more at www.janssen.com/uk . Follow us at www.twitter.com/JanssenUK . Janssen-Cilag Limited is a Janssen Pharmaceutical Company of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding IMBRUVICA (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 Janssen Research & Development, LLC, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including 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 Annual Report on Form 10-K for the fiscal year ended January 2, 2022, 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 or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

[1] National Institute for Health and Care Excellence. Final Draft Guidance. Ibrutinib with venetoclax for untreated chronic lymphocytic leukaemia. April 2023.

[2] CLL Support. About CLL, SLL, and MBL. Available at https://www.cllsupport.org.uk/information-support/about-cll. Last accessed April 2023.

[3] Macmillan Cancer Support. Chronic lymphocytic leukaemia (CLL). Available at https://www.macmillan.org.uk/cancer-information-and-support/leukaemia/chronic-lymphocytic-leukaemia-cll#:~:text=About%203%2C800%20people%20in%20the,on%20other%20types%20of%20leukaemia. Last accessed April 2023.

[4] Cancer Research UK. Ibrutinib (Imbruvica). Available at https://www.cancerresearchuk.org/about-cancer/treatment/drugs/ibrutinib. Last accessed April 2023.

[5] Jain N et al. Ibrutinib and Venetoclax for First-Line Treatment of CLL. N Engl J Med. 2019;380:2095-2103.

[6] Imbruvica 140mg film coated tablets. Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/10025/smpc. Last accessed April 2023.

[7] Bewarder M, et al. Current Treatment Options in CLL. Cancers (Basel). 2021;13(10):2468.

[8] Moreno C. Standard treatment approaches for relapsed/refractory chronic lymphocytic leukemia after frontline chemoimmunotherapy. Hematology Am Soc Hematol Educ Program. 2020;2020:33-40.

CP-385487 | April 2023