Business Wire

Janssen Submits Application to the EMA to Expand Use of IMBRUVICA® (ibrutinib) in Previously Untreated Chronic Lymphocytic Leukaemia Patients

Del

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.

About CLL

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.

About Janssen

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.

###

References

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.

October 2015

PHEM/IBR/1015/0003

Contact information

Janssen
Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Email: nbuhl@its.jnj.com
or
Investor Relations:
Lesley Fishman
Phone: +1 732-524-3922
or
Louise Mehrotra
Phone: +1 732-524-6491

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

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

Proton OnSite Has Been Awarded a Contract for Approximately USD 1.8 Million and Assumes the Lead Role in the US Government Advanced Water Splitting Benchmarking Project23.10.2017 21:02Pressemelding

Proton OnSite (Proton), a wholly owned subsidiary of Nel ASA, Oslo Norway (Nel, OSE:NEL) has been awarded a contract for approximately USD 1.8 million to participate in the US Department of Energy’s (DOE’s) Advanced Water Splitting Benchmarking Project. This is a critical piece of DOE’s HydroGEN Energy Materials Network (EMN) consortium, which was launched to accelerate the discovery and development of materials for low cost hydrogen production, enabling energy storage, resiliency and economic opportunities across sectors. Proton will work with DOE National Laboratories and lead a team to ensure that all experimental results across the water splitting research community are properly vetted, standards are set for comparison, and roadmaps are developed including research priorities and capability needs. Kathy Ayers, Proton’s Vice President of Research and Development, has been named overall project

SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico23.10.2017 17:14Pressemelding

SES Networks' high throughput and fibre-like satellite connectivity service, the stratospheric balloons operated by X, Alphabet’s self-described “moonshot factory”, and local telecommunications expertise are playing a key role in restoring 4G/LTE connectivity in disaster-affected Puerto Rico, SES announced today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023006165/en/ SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico (Photo: Business Wire) The connectivity is powered by Project Loon's targeted cell coverage and SES Networks' O3b FastConnect, a rapidly deployable satellite terminal delivering fibre-like performance. Together with local technology partners, SES Networks and X are providing reliable high-performance connectivity to Puerto Ricans whose lives have been dev

Sagemcom Unveils the Next-Generation Multi-Gigabit Solutions23.10.2017 16:05Pressemelding

AFTER THE SUCCESS OF ITS ONE GIGABIT GATEWAY RANGE, SAGEMCOM RELEASES TO THE OPERATORS THE NEXT GENERATION MULTI-GIGABIT GATEWAYS – VDSL 35B / G.FAST / PON, 2.5G/10G PON, DOCSIS 3.1 – INTEGRATING HIGH EFFICIENCY 802.11AX Wi-Fi, IN ADDITION TO NEW SMART HOME CONNECTIVITY SOLUTIONS INCLUDING DISTRIBUTED WI-FI, VOICE CONTROL AND HOME AUTOMATION. The VDSL 35B / G.fast / FTTH / PON universal gateway, F@st 5380, integrates G.fast 212MHz, GPON and 802.11ax Wi-Fi, enabling the operators to deliver Multi-Gigabit end-to-end services, and to meet the growing bandwidth required by the end-users. F@st 5380 benefits from the last innovations of the in-house field proven Sagemcom SWANTM software suite including big data, Wi-Fi distribution, smart diagnostics… The next generation Fiber gateways range includes two products: F@st 5688ax for 10G PON (XGS-PON

Moody’s Analytics Launches the CreditLens™ Platform23.10.2017 15:43Pressemelding

Moody’s Analytics has launched the CreditLens platform, our next-generation credit origination and risk monitoring solution. This new platform offers flexibility, configurability, and efficiency to lending institutions striving to establish smarter and leaner loan origination practices. The CreditLens platform reduces time-to-decision while tapping into powerful models and insightful analytics that help lenders manage risk and drive productivity. Lenders gain efficiency from the solution’s automated spreading capability and a flexible model authoring module. They also gain deep insights from built-in Moody’s Analytics Risk Grading features and Business Insights dashboards, which provide a complete view of the lender’s credit relationships. Automation in the platform also reduces errors and preserves data lineage throughout the credit assessment and origination process.

Knopp Biosciences Announces Renewal of NIH Blueprint Grant Award for Advancing KCNQ2 Modulators in Epilepsy23.10.2017 15:11Pressemelding

Knopp Biosciences LLC today announced the renewal and expansion of its grant award from the National Institutes of Health Blueprint Neurotherapeutics Network to advance novel treatments for epilepsy. The Phase 2 award under the NIH Small Business Innovation Research (SBIR) program anticipates NIH support of up to $2 million over the next three years of the project, subject to satisfactory completion of milestones. The renewal follows the successful completion of all milestones under a previously awarded Phase 1 grant of $400,000. Knopp is directing its potassium channel activator program to preclinical and clinical development of small-molecule drug candidates against a validated, anti-seizure pharmaceutical target encoded by the KCNQ2 gene. Knopp intends to advance novel, small-molecule KCNQ2 activators in neonatal epileptic encephalopathy, a rare disorder caused by inherit

HCL Technologies Powers Volvo Ocean Race 2017-1823.10.2017 13:02Pressemelding

The 2017-18 edition of the Volvo Ocean Race was flagged off at Alicante, Spain, with HCL Technologies as the strategic IT services provider. The leading global IT services company has provided end-to-end infrastructure support as well as connectivity between the Race Village and the Command Centre in Alicante further connecting them to 12 Host Cities on the race route globally. The world's longest and toughest professional sporting event began at Alicante and will finish eight months later at The Hague. At the flag-off, Jordi Neves, Chief Digital Officer, Volvo Ocean Race, said: “Over four decades, Volvo Ocean Race has drawn some of the greatest ever sailors. This edition of the race will be more digitally focused than before, with HCL as the strategic IT services provider. This edition is also special for us as we embark on a major Sustainability Program in partnership wi

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom