Janssen Submits Application to the EMA to Expand Use of IMBRUVICA® (ibrutinib) in Previously Untreated Chronic Lymphocytic Leukaemia Patients
Janssen-Cilag International NV announced today the submission of a Type II variation application to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorisation for IMBRUVICA® (ibrutinib) to include previously untreated patients with chronic lymphocytic leukaemia (CLL). IMBRUVICA is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie company. Janssen affiliates market IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except for the United States, where Janssen Biotech, Inc. and Pharmacyclics LLC co-market it.
The filing is based on data from the randomised, multi-centre, open-label Phase 3 RESONATETM-2 (PCYC-1115) clinical trial assessing the use of IMBRUVICA versus chlorambucil in patients with treatment-naïve CLL or small lymphocytic lymphoma (SLL) aged 65 years or older.
The RESONATE-2 trial, which was sponsored by Pharmacyclics LLC, enrolled 269 patients in the U.S., EU and other regions. Patients were randomised to receive either IMBRUVICA 420 mg orally, once daily until progression or toxicity, or chlorambucil 0.5 to 0.8 mg/kg on days 1 and 15 of each 28-day cycle for up to 12 cycles. At the time of the final analysis the primary endpoint was met, with IMBRUVICA shown to be superior to chlorambucil in terms of progression-free survival (PFS). In addition, IMBRUVICA demonstrated significant improvements in key secondary efficacy endpoints, including overall survival (OS), overall response rate (ORR) and in haematologic function. The safety findings were consistent with previous studies.
The data have been accepted for presentation at an upcoming medical conference and for publication in a peer-reviewed journal. More information about the study can be found on www.clinicaltrials.gov. On 14 September 2015, Janssen announced that a supplemental New Drug Application (sNDA) was filed with the U.S. Food and Drug Administration for treatment-naïve patients with CLL based on these data.1
“This submission to expand the use of IMBRUVICA for patients with treatment-naïve CLL is a significant step forward in transforming the treatment journey for these patients,” said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. “Our ongoing efforts to further investigate IMBRUVICA in additional populations is part of our commitment to improving outcomes for patients with difficult to manage cancers.”
- ENDS -
About IMBRUVICA ® (ibrutinib)
IMBRUVICA (ibrutinib) is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B cells.2 By blocking this BTK protein, IMBRUVICA helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer.3
IMBRUVICA is currently approved in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL); adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line patients with CLL in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy;4 and in adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.4 Regulatory approval for additional uses has not yet been granted. Investigational uses for ibrutinib, alone and in combination with other treatments, are under way in several blood cancers including CLL, MCL, WM, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), multiple myeloma (MM) and marginal zone lymphoma (MZL).
IMBRUVICA is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics, LLC, an AbbVie company. Janssen affiliates market IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except for the United States, where Janssen Biotech, Inc. and Pharmacyclics LLC co-market it. Janssen and Pharmacyclics are continuing an extensive clinical development programme for IMBRUVICA, including Phase 3 study commitments in multiple patient populations – please see the IMBRUVICA summary of product characteristics for further information.
In most patients, CLL is generally a slow-growing blood cancer of the white blood cells called B-lymphocytes.5 The median age at diagnosis is 72 years,6 and incidence rates among men and women in Europe are approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.7 CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years according to the stage of disease.8 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options each time. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
CLL cells are found in both the lymphatic system and the blood.9 When the cancer cells are located mostly in the lymph nodes, the disease is called small lymphocytic lymphoma (SLL). Both CLL and SLL are considered different manifestations of the same entity, as classified in the fourth edition of the World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues.10
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed, and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on haematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious diseases (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found on www.janssen-emea.com. Follow us on www.twitter.com/janssenEMEA for our latest news.
Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
1. Janssen Biotech, Inc. IMBRUVICA® (ibrutinib) Supplemental New Drug Application for Treatment-naive Chronic Lymphocytic Leukemia Submitted to the U.S. FDA. http://www.prnewswire.com/news-releases/imbruvica-ibrutinib-supplemental-new-drug-application-for-treatment-naive-chronic-lymphocytic-leukemia-submitted-to-the-us-fda-300142150.html. Last accessed October 2015.
2. O’Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014;15:48-58.
3. European Medicines Agency. How is the medicine expected to work? http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/06/human_orphan_001058.jsp&mid=WC0b01ac058001d12b. Last accessed October 2015.
4. Imbruvica Summary of Product Characteristics, September 2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf Last accessed October 2015.
5. American Cancer Society. What is chronic lymphocytic leukemia? Available at: http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-what-is-cll. Last accessed October 2015.
6. Eichhorst B, Dreyling M, Robak T, Montserrat E, Hallek M; ESMO Guidelines Working Group. Chronic lymphocytic leukemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2011;22(Suppl.6):vi50-vi54.
7. 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.
8. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators in chronic lymphocytic leukemia. Cancer Control 2012;19:18-25.Stilgenbauer S, Zenz T. Understanding and Managing Ultra High-Risk Chronic Lymphocytic Leukemia. Hematology 2010;481-8.
9. Hallek M. Signaling the end of chronic lymphocytic leukemia: new frontline. Blood. 2013;122:3723-34.
10. Santos FP, O’Brien S. Small lymphocytic lymphoma and chronic lymphocytic leukemia are they the same disease? Cancer J. 2012;8:396-403.
Mobile: +353 (0)85-744-6696
Phone: +1 732-524-3922
Phone: +1 732-524-6491
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50 | Pressemelding
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&
SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01 | Pressemelding
We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact email@example.com . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough firstname.lastname@example.org
NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 15:32 | Pressemelding
NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such
CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 15:29 | Pressemelding
Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen
Full Core of Westinghouse Fuel Achieved at South-Ukraine Nuclear Power Plant Unit 319.7.2018 13:25 | Pressemelding
Westinghouse Electric Company announced today that Ukraine’s State Enterprise National Nuclear Energy Generation Company (SE NNEGC) Energoatom’s South-Ukraine NPP Unit 3 near Yuzhnoukrainsk in Mykolaiv province was loaded with a full core of Westinghouse VVER-1000 fuel. This is the first unit in Ukraine to operate with Westinghouse VVER-1000 fuel assemblies as the sole fuel source. “Westinghouse began supplying fuel to Ukraine in 2005, when the first lead test assemblies were delivered to South-Ukraine Unit 3,” said Aziz Dag, vice president and managing director, Northern Europe. “We are proud to continue supporting Ukraine with their energy diversification by supplying a full core of Westinghouse VVER-1000 fuel to our customer, Energoatom.” Westinghouse currently supplies fuel to six of Ukraine’s 15 nuclear power reactors. Beginning in 2021, the number of reactors with Westinghouse fuel will increase to seven. “Westinghouse has made significant investments over the last several years
Seoul Semiconductor Delivers Its Innovative LED "SunLike" to U.S. Lighting Market19.7.2018 13:00 | Pressemelding
Seoul Semiconductor Co., Ltd. (KOSDAQ:046890), a market leader in LED (light emitting diode) design and manufacturing, announced that its innovative LED “SunLike” is applied to brand new lightings to be launched by three lighting premium brands in U.S., Pure Edge Lighting, LEDRAbrands, Inc. and Elite Lighting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180719005377/en/ The product of LEDRAbrands, Inc., NU4RA-SUN, which applied SunLike of Seoul Semiconductor (Photo: Business Wire) Seoul Semiconductor supplies SunLike to pendant lighting for Pure Edge, a U.S. lighting solution company. It is applied to high-end lighting for museums and art galleries that require the highest color quality. The leading lighting design companies, LEDRAbrands, Inc. and Elite Lighting, apply SunLike to downlights and spotlights respectively. “We have selected Seoul Semiconductor’s innovative LED SunLike for our human centric lighting and believ