Decision could significantly improve transplant outcomes for patients
with multiple myeloma
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV (Janssen) announced today that the
European Commission (EC) has approved the use of VELCADE®
(bortezomib) as induction therapy (a first
therapeutic option) in combination with dexamethasone (VD) or
thalidomide and dexamethasone (VTD).1 This licence extension
will apply to adult patients with previously-untreated multiple myeloma who
are eligible for high-dose chemotherapy with haematological stem cell
transplantation.
Until now, VELCADE's (bortezomib) indication has been limited to its
use, in combination with melphalan and prednisone, in adult patients
with multiple myeloma that are previously untreated and ineligible
for stem cell transplant, and as a single agent in advanced multiple
myeloma.2 Multiple myeloma, a type of blood cancer, currently
affects around 60,000 people in Europe.3 This decision could
mean significantly improved outcomes for many patients with this disease.
The approval by the EC was based on the analysis of data from two Phase
III trials (IFM-2005-01, PETHEMA/GEM05) which demonstrated that
treatment with VELCADE-based induction resulted in improvements in
post-induction and post-transplant response rates and in
progression-free survival (PFS); PFS and overall survival (OS) were
secondary endpoints.
The trials studied the use of VELCADE-based regimens VD and VTD,
compared to non-VELCADE-based regimens of vincristine plus doxorubicin
and dexamethasone, or thalidomide and dexamethasone, respectively, as
induction therapy prior to autologous stem cell transplant in adult
patients with previously-untreated multiple myeloma.4,5
# ENDS #
Overview of the IFM-2005-01 and PETHEMA/GEM05 studies4,5
Study IFM-2005-01 evaluated VELCADE (bortezomib) in combination with
dexamethasone (VD) compared to vincristine, plus doxorubicin and
dexamethasone (VAD). The study included patients aged 65 or under with
untreated symptomatic multiple myeloma, with measurable paraprotein in
serum (over 10 g/L or urine over 0.2 g/24h).
Results demonstrated that complete response or near complete response
rate was significantly improved in the VD group, with a 14.8 percent
response rate compared to 6.4 percent [p = 0.004] in patients
treated post induction therapy, and 35.0 percent compared to 18.4
percent [p < 0.001] respectively in those treated post first
transplantation.
PFS was 36.0 months in the VD group compared to 29.7 months [p =
0.064] in the VAD group. The OS rate at the 3 year follow up was 81.4
percent in those receiving VD compared to 77.4 percent [p =
0.508] in those treated with VAD.
Study PETHEMA/GEM05 evaluated VELCADE (bortezomib) in combination with
thalidomide and dexamethasone (VTD) compared to thalidomide and
dexamethasone (TD). It included patients with newly diagnosed and
untreated symptomatic multiple myeloma who were 65 years of age or
younger with measurable serum and/or urine M protein.
Results demonstrated an improvement in complete response rate, with 35
percent complete response in the VTD group compared to 14 percent [p
= 0.0001] in the TD group, in patients post induction, and 46 percent
compared to 24 percent in those post-transplant [OR: 2.34 (95 percent
Cl: 1.42, 3.87); p = 0.004].
A statistically significant improvement in PFS of 56.2 months was
achieved in the VTD group, compared to 28.2 months [p = 0.01] in
the TD group. OS at the 4 year follow up was 74 percent in the VTD group
compared to 65 percent in those treated with TD [p =NS].
About VELCADE (bortezomib)2
VELCADE (bortezomib) is a medicine used to treat the blood-based cancer
known as multiple myeloma. It contains an active substance called
bortezomib and is the first in a specific class of medicines known as
proteasome inhibitors. Proteasomes are present in all cells and play an
important role in controlling cell function, growth and also how cells
interact with the other cells around them. Bortezomib reversibly
interrupts the normal working of cell proteasomes causing myeloma cancer
cells to stop growing and die.
VELCADE (bortezomib) has a predictable safety profile and a favourable
benefit—risk ratio. The most common side effects reported with VELCADE
(bortezomib)include fatigue, gastrointestinal adverse
events, transient thrombocytopenia and neuropathy.
VELCADE (bortezomib)is the market leader in the treatment of
frontline non-transplant eligible multiple myeloma, with more than
400,000 patients treated worldwide. VELCADE (bortezomib)is
co-developed by Millennium Pharmaceuticals and Janssen Pharmaceutical
Companies. Millennium is responsible for commercialisation of VELCADE
(bortezomib)in the U.S., Janssen Pharmaceutical Companies
are responsible for commercialisation in Europe and the rest of the
world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical
K.K. co-promote VELCADE (bortezomib) in Japan.
Recent advances: VELCADE SUBCUTANEOUS and RETREATMENT
In June 2013, an alteration to VELCADE's (bortezomib) label was approved
by the Committee for Medicinal Products for Human Use (CHMP).
This permitted wording to include the use of VELCADE (bortezomib) as
retreatment in adult patients who have previously responded to treatment
with the same medicine.6
In 2012, the European Commission granted marketing authorisation for the
subcutaneous (under the skin) administration of VELCADE (bortezomib) in
the European Union. Subcutaneous bortezomib has fewer side effects and
offers greater convenience for patients, with similar efficacy compared
to intravenous bortezomib.7
About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone
marrow and is characterised by an excess proliferation of abnormal
plasma cells.8 It is the second most frequent form of
malignant bone marrow diseases and is a relatively rare form of cancer
that accounts for roughly one percent of all cancers and roughly two
percent of all deaths from cancer. In Europe, around 60,000 people are
living with the disease and there are 21,420 new cases and 15,000 deaths
every year.8
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
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 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.
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The original language of this press release is English. Translations
into French, German, Italian and Spanish are provided by Business Wire
as a courtesy.
References
1European Commission: Velcade as a frontline induction
therapy before stem cell transplantation. Available at: http://ec.europa.eu/health/documents/community-register/html/h274.htm#EndOfPage
Accessed August 2013.
2 VELCADE EPAR Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000539/human_med_001130.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124.
Accessed August 2013.
3 Myeloma Patients Europe — FAQs. Available at http://www.myeloma-euronet.org/en/multiple-myeloma/faq.php.
Accessed August 2013.
4 Rosiñol L et al. Blood 2012; 120: 1589-1596.
5 Harousseau J-L et al. J Clin Oncol 2010; 28:4630-4635.
6 CHMP Gives A Positive Opinion For The Use Of VELCADE As
Retreatment And For Frontline Induction Therapy Before Stem Cell
Transplantation. Press release available at: http://www.jnj.com/news/all/CHMP-Gives-A-Positive-Opinion-For-The-Use-Of-VELCADE-As-Retreatment-And-For-Frontline-Induction-Therapy-Before-Stem-Cell-Transplantation.
Accessed August 2013.
7European Commission - VELCADE subcutaneous administration.
Available at: http://ec.europa.eu/health/documents/community-register/html/h274.htm#EndOfPage.
Accessed August 2013.
8 Myeloma Patients Europe — What is multiple myeloma?
Available at: http://www.myeloma-euronet.org/en/multiple-myeloma/what-is.php.
Accessed July 2013.
MEDIA CONTACT: Satu Glawe
+49 172 294 6264
sglawe@its.jnj.com
or
INVESTOR
RELATIONS: Stan Panasewicz
+1 732-524-2524
or
Louise
Mehrotra
+1 732-524-6491
Source: Janssen
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