Recommendation based on RESONATE™-2 trial which showed IMBRUVICA
significantly improved progression-free survival and prolonged overall
survival versus chlorambucil
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a Positive Opinion, recommending broadening the
existing marketing authorisation for ibrutinib as a single agent for the
treatment of adult patients with previously untreated chronic
lymphocytic leukaemia (CLL).
Ibrutinib is approved for the treatment of adult patients with relapsed
or refractory mantle cell lymphoma (MCL), or adult patients with chronic
lymphocytic leukaemia (CLL) who have received at least one prior
therapy, or in first line in the presence of 17p deletion or TP53
mutation (genetic mutations typically associated with poor treatment
outcomes) in patients unsuitable for chemo-immunotherapy 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.1
The Positive Opinion of the CHMP was based on data from the Phase 3,
randomised, open-label RESONATE™-2 (PCYC-1115) clinical trial, as
recently published in The New
England Journal of Medicine (NEJM).2 Findings
showed ibrutinib provided a significant improvement in all efficacy
endpoints versus chlorambucil in patients aged 65 or older with newly
diagnosed CLL. The progression-free survival (PFS) rate at 18 months was
90 percent for ibrutinib versus 52 percent for chlorambucil.2
Ibrutinib also significantly prolonged overall survival (OS) (HR=0.16
percent CI, 0.05, 0.56; P=0.001), with a 24-month survival rate of 98
percent, compared to 85 percent for patients in the chlorambucil arm.2
The safety of ibrutinib in the treatment-naïve CLL patient population
was consistent with previously reported studies.2 The most
common adverse reactions (ARs) (≥20 percent) of any Grade in the
RESONATE-2 trial for ibrutinib were diarrhoea (42 percent), fatigue (30
percent), cough (22 percent) and nausea (22 percent).2
CLL is a chronic disease, and the prevalence rate in Europe among men
and women is approximately 5.87 and 4.01 cases per 100,000 persons per
year, respectively. Median overall survival ranges between 18 months and
more than 10 years according to the stage of disease.3
"Janssen is proud to be leading the charge with our ongoing efforts to
transform the treatment experience for patients with difficult to treat
blood cancers, such as CLL," said Jane Griffiths, Company Group
Chairman, Janssen Europe, Middle East and Africa. "Ibrutinib continues
to demonstrate impressive clinical results, and the data on which this
recommendation is based once again highlight its potential to deliver
improved patient outcomes for suitable patients."
This regulatory milestone follows the decision by the U.S. Food and Drug
Administration on 04
March 2016, to approve the expanded use of ibrutinib capsules for
treatment-naïve patients with CLL.
#ENDS#
About Ibrutinib
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.4
By blocking this BTK protein, ibrutinib helps kill and reduce the number
of cancer cells. It also slows down the progression of the cancer.1
Ibrutinib 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;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.5
Regulatory approval for additional uses has not yet been granted.
Investigational uses for ibrutinib, alone and in combination with other
treatments, are underway in several blood cancers.
Ibrutinib is co-developed by Cilag GmbH International, a member of the
Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie
company. Janssen affiliates market ibrutinib in EMEA (Europe, Middle
East and Africa) as well as the rest of the world, except in the United
States, where Janssen Biotech, Inc. and Pharmacyclics co-market it.
Janssen and Pharmacyclics are continuing an extensive clinical
development programme for ibrutinib, including Phase 3 study commitments
in multiple patient populations - please see the ibrutinib
summary of product characteristics for further information.
About RESONATE™-2
Findings of the RESONATE™-2 (PCYC-1115) trial showed ibrutinib provided
a significant improvement in progression-free survival and other key
clinical endpoints versus chlorambucil in patients aged 65 or older with
newly diagnosed CLL. The progression-free survival (PFS) rate at 18
months was 90 percent for ibrutinib versus 52 percent for chlorambucil.2
Ibrutinib also significantly prolonged overall survival (OS) (HR=0.16
percent CI, 0.05, 0.56; P=0.001), with a 24-month survival rate of 98
percent, compared to 85 percent for patients in the chlorambucil arm.2
The safety of ibrutinib in the previously untreated CLL patient
population was consistent with previously reported studies.2,5
The adverse reactions (AR) reported in the RESONATE-2 trial reflect
exposure to ibrutinib with a median duration of 17.4 months versus a
median exposure to chlorambucil of 7.1 months: nearly 2.5 times longer
exposure for ibrutinib.2 The most common non-haematological
ARs of Grade ≥3 were pneumonia, hypertension and diarrhoea (all 4
percent).2
About CLL
In most patients, CLL is generally a slow-growing blood cancer of the
white blood cells called B-lymphocytes.6 The median age at
diagnosis is 72 years,7 and incidence rates among men and
women in Europe are approximately 5.87 and 4.01 cases per 100,000
persons per year, respectively.8 CLL is a chronic disease;
median overall survival ranges between 18 months and more than 10 years
according to the stage of disease.3 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.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.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.
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 haematological
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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
product development. 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-Cilag International NV, any of the other Janssen
companies and/or Johnson & Johnson. Risks and uncertainties include, but
are not limited to: challenges and uncertainties inherent in product
development, including the uncertainty of clinical success and
regulatory approvals; uncertainty of commercial success; competition,
including technological advances, new products and patents attained by
competitors; manufacturing difficulties and delays; challenges to
patents; product efficacy or safety concerns resulting in product
recalls or regulatory action; changes in behavior and spending patterns
or financial distress of purchasers of health care products and
services; and trends toward health care cost containment. A further list
and description 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 3, 2016, including in Exhibit 99 thereto, 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 or Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments.
###
April 2016
PHEM/IBR/0216/0002
References
1. European Medicines Agency. IMBRUVICA (ibrutinib). Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003791/human_med_001801.jsp&mid=WC0b01ac058001d124
Last accessed March 2016.
2. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib vs
chlorambucil in treatment-naïve chronic lymphocytic leukemia. N Engl
J Med. 2015;373:2425-37.
3. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators in
chronic lymphocytic leukemia. Cancer Control. 2012;19:18-25.
4. 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.
5. Imbruvica summary of product characteristics, December 2015.
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf
Last accessed March 2016.
6. American Cancer Society. Chronic lymphocytic leukemia detailed guide.
Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf
Last accessed March 2016.
7. 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.
8. 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.
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