Janssen Announces European Commission Decision for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved a variation to the marketing authorisation for IMBRUVICA® (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients. The decision is based on data from the Phase 3 E1912 study that showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR).2,3 The study was designed and conducted in the United States (U.S.) by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the U.S. National Institutes of Health.2,3
The study evaluated 529 previously untreated patients with CLL aged 70 years or younger (median age, 58 years) who were randomly assigned to receive six cycles of ibrutinib plus rituximab (IR) (n=354), followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR (n=175).2
At a median follow-up of 37 months, patients treated with IR lived longer without disease progression, with a progression-free survival (PFS) rate of 88 percent, compared to 75 percent for patients treated with FCR (hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.22-0.52; p<0.0001).1 The study also showed an overall survival (OS) advantage for patients treated with the IR regimen.1 The primary study results were published previously in The New England Journal of Medicine , and with extended 48-month follow-up, as presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the initial treatment benefit is maintained.2,3
“Historically, chemotherapy with FCR has been the standard of care, or first treatment prescribed for patients with previously untreated CLL,” said John Gribben, MD DSc, Professor of Medical Oncology at St Bartholomew's Hospital, Barts Cancer Institute, Queen Mary, University of London. “This decision by the EC is an important step in being able to offer patients with CLL a non-chemotherapy option in the frontline setting, building on the established efficacy and safety we have come to expect from ibrutinib-based therapy.”
“We are delighted with the EC’s decision approving the use of ibrutinib in combination with rituximab for these patients,” said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. “This new non-chemotherapy combination regimen can offer extended remission, as well as fewer chemotherapy-related side effects for patients living with CLL.”
Adverse events for the IR arm were consistent with the known safety profiles for ibrutinib and rituximab.1 The most common adverse reactions seen with ibrutinib include diarrhoea, neutropaenia, musculoskeletal pain, rash, haemorrhage (e.g., bruising), thrombocytopenia, nausea, pyrexia, arthralgia, and upper respiratory tract infection.4 The most common serious adverse reactions (which may affect more than 1 in 20 people) include neutropenia, lymphocytosis, thrombocytopenia, pneumonia, and hypertension.4
“Ibrutinib is the most comprehensively studied Bruton’s tyrosine kinase (BTK) inhibitor with the longest follow-up across eight positive Phase 3 trials in CLL to date, and is recognised as an important advancement in treatment for patients with CLL,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “This latest milestone highlights our commitment to studying the full potential of ibrutinib and in developing regimens which can transform what a CLL diagnosis means for patients going forward.”
This announcement comes after the U.S. Food and Drug Administration’s (FDA) approval of this expanded indication for ibrutinib in April 2020.
#ENDS#
About ibrutinib
Ibrutinib is a once-a-day, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally.4 Ibrutinib blocks the BTK protein; the BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signalling is needed by specific cancer cells to multiply and spread.5 By blocking BTK, ibrutinib may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.6
Indications for which ibrutinib is approved in Europe include:4
- Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with rituximab or obinutuzumab for the treatment of adult patients with previously untreated CLL, and 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
- Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
- Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 99 countries for at least one indication, and to date, has been used to treat more than 200,000 patients worldwide.7
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 chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.8 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.9 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.10
The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
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, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news. Janssen-Cilag and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies 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 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 materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, 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 behaviour 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 December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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 Imbruvica FDA Highlights of Prescribing Information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf. Last accessed September 2020.
2 Shanafelt TD, Wang XV, Kay NE, Hanson CA, O’Brien S, Barrientos J, Jelinek DF, Braggio E, Leis JF, Zhang CC, Coutre SE. Ibrutinib–rituximab or chemoimmunotherapy for chronic lymphocytic leukemia. New England Journal of Medicine. 2019 Aug 1;381(5):432-43.
3 Shanafelt TD, Wang V, Kay NE, Hanson CA, O'Brien SM, Barrientos JC, Jelinek DF, Braggio E, Leis JF, Zhang CC, Coutre S. Ibrutinib and Rituximab Provides Superior Clinical Outcome Compared to FCR in Younger Patients with Chronic Lymphocytic Leukemia (CLL): Extended Follow-up from the E1912 Trial. ASH 2019 Oral Presentation. Abstract #33.
4 Imbruvica Summary of Product Characteristics, January 2020. Available at: https://www.ema.europa.eu/documents/product-information/imbruvica-epar-product-information_en.pdf Last accessed September 2020.
5 Turetsky, A, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014).
6 de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
7 Janssen Data on File (EMEA-SR-1492). Global number of cumulative patients treated with Ibrutinib since launch. July 2020.
8 American Cancer Society. What is chronic lymphocytic leukemia? Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html Last accessed September 2020.
9 Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood. 2010;116:3724–34.
10 Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl.5):v78-v84.
CP-175683
September 2020
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200907005149/en/
Contact information
Media Enquiries:
Noah Reymond
Mobile: +31 621-385-718
Email: NReymond@ITS.JNJ.com
Investor Relations:
Christopher DelOrefice
Office: +1 732-524-2955
Jennifer McIntyre
Office: +1 732-524-3922
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 12:13:00 EEST | Press release
SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 02:00:00 EEST | Press release
The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster than the global economy, generating significant commercial opportunities as long as the mounting challenges of climate change, labour shortages and infrastructure gaps are addressed. Inbound and outbound trips increasing fast Asia is on track to become the world’s fastest-growing tourism economy, with the direct travel and tourism GDP contribution expected to exceed 7% across the region by 2034. Notably, India and China
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 22:00:00 EEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 15:59:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
Frost & Sullivan Recognizes Novotech as 2025 Global Biotech CRO Company of the Year3.7.2025 15:05:00 EEST | Press release
In recognition of its innovation, client-focused delivery, and global impact, Novotech has been awarded the 2025 Global Biotechnology Contract Research Organization (CRO) Company of the Year by Frost & Sullivan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703950144/en/ Novotech Wins Global CRO Award Novotech is a globally recognized full-service clinical CRO and scientific advisory firm, trusted by biotech and small- to mid-sized pharmaceutical companies to advance their drug development programs at every phase. With a global footprint spanning Asia-Pacific, North America, and Europe, Novotech supports over 5,000 clinical trial sites and a distributed team of experts delivering seamless, end-to-end solutions across geographies. “Novotech is redefining biotech-focused clinical research through AI-driven innovation, global expansion, and a client-embedded partnership model. With a clear vision to be the CRO of choice for
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom