The submission is for chronic lymphocytic leukemia (CLL)/small
lymphocytic leukemia (SLL) and mantle cell lymphoma (MCL), two
difficult-to-treat diseases
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV (Janssen) announced today it has
submitted a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) for ibrutinib for the treatment of adult patients
with relapsed or refractory chronic lymphocytic leukemia (CLL)/small
lymphocytic leukemia (SLL) or relapsed or refractory mantle cell
lymphoma (MCL), two forms of blood cancer.
Ibrutinib is administered orally, once-daily and is the first in a class
of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Data
suggest ibrutinib covalently bonds to BTK in malignant B cells, shutting
down major proliferation and survival pathways. Ibrutinib is being
developed by Janssen with Pharmacyclics, Inc. for the treatment of
several forms of blood cancer. If approved, ibrutinib will be the first
commercially available therapy targeting BTK.
"The EMA Marketing Authorisation Application is an important milestone
in the development of ibrutinib," said Jane Griffiths, Group Company
Chairman of Janssen Europe, the Middle East and Africa (EMEA). "At
Janssen, we are dedicated to developing solutions that prolong and
improve the lives of patients. If approved, ibrutinib will address a
great unmet need for patients with CLL/SLL and MCL who have previously
failed or become resistant to previous treatment."
The EMA filings follow the New Drug Application submission of ibrutinib
to the U.S. Food and Drug Administration which was announced on 10 July
2013, for its use in the treatment of previously treated patients with
CLL/SLL or MCL.
CLL/SLL and MCL belong to a group of blood cancers, known as B-cell
malignancies, originating from B cells, a type of white blood cell
(lymphocyte).1 CLL/SLL and MCL, are complex diseases that can
be challenging to treat. As a result, many patients will relapse after a
specific treatment and may require multiple treatments over the course
of their disease.
#ENDS#
About Ibrutinib
Ibrutinib is the first in a class of medicines called Bruton's tyrosine
kinase (BTK) inhibitors. BTK is an important protein involved in
mediating the cellular signaling pathways which control B cell
maturation and survival. In malignant B cells, there is excessive
signaling through the B cell receptor signaling (BCR) pathway, which
includes BTK. The malignant cell ignores the natural signal to die and
continues to develop and proliferate. Malignant cells migrate and adhere
to protective environmental areas such as the lymph nodes where they
proliferate and survive. Ibrutinib is the first in a new class of drugs
specifically designed to target and inhibit BTK. Ibrutinib forms a
strong covalent bond with BTK, which inhibits the excessive transmission
of cell survival signals within the malignant B cells and stops their
excessive build up in these protected environmental areas. The efficacy
and safety of ibrutinib alone and in combination with other treatments
is being studied in several blood cancers.2,3,4,5,6
About Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Leukemia (SLL)
CLL is a usually slow growing blood cancer that most commonly originates
from B cells, a type of white blood cell (lymphocyte) that develops in
the bone marrow. B cells are part of the immune system and play an
important role in fighting infection in the body. CLL is the most common
adult leukemia in the Western world, with the median age at diagnosis
being primarily those over 70 years old. The incidence rates among men
and women in Europe are approximately 5.87 and 4.01 cases per 100,000
persons per year, respectively. CLL is a chronic disease; median overall
survival ranges between 18 months and more than 10 years according to
the stage of disease. When cancer cells are located mostly in the lymph
nodes, the disease is called small lymphocytic lymphoma (SLL).7,8,9,10,11,12
About Mantle Cell Lymphoma (MCL)
MCL is a rare and aggressive blood cancer that usually occurs in older
adults, with the median age at diagnosis being 65 years. The disease
typically begins in the bone marrow, but can spread to other tissues
such as bone marrow, liver and spleen. The incidence rates among men and
women in Europe are approximately 0.64 and 0.27 cases per 100,000
persons per year, respectively. MCL patients generally have a poor
prognosis. Median overall survival is typically three to four years, and
only one to two years in patients following the first relapse. 13,14,15,16
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated
to addressing and solving the most important unmet medical needs of our
time, including oncology, immunology, neuroscience, infectious disease,
and cardiovascular and metabolic diseases. Driven by our commitment to
patients, Janssen develops innovative products, services and healthcare
solutions to help people throughout the world. More information can be
found at www.janssen-emea.com
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 hematologic 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, individualized use of our therapies; as
well as safe and effective identification and treatment of early changes
in the tumor microenvironment.
Janssen and Pharmacyclics Strategic Partnership
Ibrutinib is being co-developed as part of a strategic partnership
between Janssen and Pharmacyclics, Inc. Both companies are responsible
for the development, manufacturing and commercialisation of ibrutinib.
In Europe, Janssen is the lead party for the commercialisation of
ibrutinib, if approved. Details about the complete ibrutinib clinical
program are posted on clinicaltrials.gov.
(This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. 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 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 Pharmaceutical Companies and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to, general
industry conditions and competition; economic factors, such as interest
rate and currency exchange rate fluctuations; technological advances,
new products and patents attained by competitors; challenges inherent in
new product development, including obtaining regulatory approvals;
challenges to patents; changes in behavior and spending patterns or
financial distress of purchasers of health care products and services;
changes to governmental laws and regulations and domestic and foreign
health care reforms; trends toward health care cost containment; and
increased scrutiny of the health care industry by government agencies. A
further list and description of these risks, uncertainties and other
factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report
on Form 10-K for the fiscal year ended December 30, 2012. Copies of this
Form 10-K, as well as subsequent 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 undertake to update any forward-looking
statements as a result of new information or future events or
developments.)
# # #
References
1. National Cancer Institute. Definition: B cell. Available from: http://www.cancer.gov/dictionary?cdrid=45611.
Accessed May 14, 2013.
2. Qiu Y, Kung HJ. Signaling network of the Btk family kinases. Oncogene
2000;19:5651-61.
3. Shaffer AL, Rosenwald A, Staudt LM. Lymphoid malignancies: the dark
side of B-cell differentiation. Nat Rev Immunol. 2002;2:920-32.
4. Puri KD, di Paolo JA, Gold MR. B-cell receptor signaling inhibitors
for treatment of autoimmune inflammatory diseases and B-cell
malignancies. Int Rev Immunol 2013;32:397-427.
5. Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway
as a therapeutic target in CLL. Blood 2012;120:1175-84.
6. Akinleye A, Chen Y, Mukhi N, Song Y, Liu D. Ibrutinib and novel BTK
inhibitors in clinical development. J Hematol Oncol 2013;6:59.
7. Parker, T. Chronic lymphocytic leukemia: prognostic factors and
impact on treatment. Discovery Medicine. 2011; 57.
8. SEER Statistics. Fact Sheets: Chronic lymphocytic leukemia. Available
from: http://seer.cancer.gov/statfacts/html/clyl.html.
Accessed March 6, 2013.
9. American Cancer Society. Detailed guide: what is chronic lymphocytic
leukemia. Available from: http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-what-is-cll.
Accessed March 6, 2013.
10. 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.
11. Cancer Research UK. The most common types of non-Hodgkins lymphoma.
Available from: http://www.cancerresearchuk.org/cancerhelp/type/non-hodgkins-lymphoma/about/types/the-most-common-types-of-non-hodgkins-lymphoma#sll.
Accessed March 14, 2013.
12. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators
in chronic lymphocytic leukemia. Cancer Control 2012;19:18-25.
13. McKay P, Leach M, Jackson R, et al. Guidelines for the investigation
and management of mantle cell lymphoma. Br J Haematol 2012;159:405-26.
14. Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts. Available
from: http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/lymphoma/pdf/mantlecelllymphoma.pdf.
Accessed May 14, 2013.
15. Smedby KE, Hjalgrim H. Epidemiology and etiology of mantle cell
lymphoma and other non-Hodgkin lymphoma subtypes. Semin Cancer Biol
2011;21:293-8.
16. Goy A, Bernstein SH, Kahl BS, et al. Bortezomib in patients with
relapsed or refractory mantle cell lymphoma: updated time-to-event
analyses of the multicenter phase 2 PINNACLE study. Ann Oncol
2009;20:520-5.
Janssen
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Source: Janssen
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