Decision could significantly improve transplant outcomes for patients with multiple myeloma
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
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
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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
Recent advances: VELCADE SUBCUTANEOUS and RETREATMENT
In 2012, the
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
The Janssen Pharmaceutical Companies of
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
The original language of this press release is English. Translations into French, German, Italian and Spanish are provided by Business Wire as a courtesy.
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.
3 Myeloma Patients Europe — FAQs. Available at http://www.myeloma-euronet.org/en/multiple-myeloma/faq.php.
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.
8 Myeloma Patients Europe — What is multiple myeloma?
Available at: http://www.myeloma-euronet.org/en/multiple-myeloma/what-is.php.
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