EMA Approves Update to Velcade(R) (bortezomib) Label to Include Long Term (3 Year Follow up) Overall Survival Benefit in Previously Untreated Patients with Multiple MyelomaBy Janssen-cilag, PRNE
Monday, June 14, 2010
Additional Data Demonstrating Efficacy of Velcade Presented at the 15th Congress of the European Hematology Association
BEERSE, Belgium, June 15, 2010 - Janssen-Cilag today welcomes the approval by the European Commission of
the update to the Summary of Product Characteristics (SmPC) for Velcade(R)
(bortezomib) for the treatment of patients with multiple myeloma. The update
includes extended follow-up data on overall survival rates at three years
post-treatment. The decision follows a positive recommendation by the
Committee for Medicinal Products for Human Use (CHMP), the scientific
committee of the European Medicines Agency (EMA).
The CHMP reviewed clinical evidence from a prospectively defined survival
update of the phase III international VISTA (Velcade as Initial Standard
Therapy in Multiple Myeloma) study, which shows a significantly improved
overall survival of 68.5% for patients treated with Velcade plus melphalan
and prednisone (Vc+M+P), compared to 54% (p=0.0008) for patients on melphalan
and prednisone (M+P) alone after three years of treatment. The study also
showed a significantly higher complete response rate of 30% for Vc+M+P versus
4% for M+P alone. 
The Pharmacological Properties section of the SmPC for Velcade now
includes these updated efficacy results following the pre-planned survival
follow-up analysis in the VISTA study. 
In addition, data from more than ten studies demonstrating the efficacy
of Velcade in a number of different treatment settings were presented this
weekend at the 15th Congress of the European Hematology Association in
The data presented highlight the evidence supporting the use of Velcade
as multiple myeloma therapy in the first-line and second-line settings and
include: (1) a phase II study of Velcade (Ludwig et al.) as induction therapy
showing positive complete response rates ; (2) data from RETRIEVE
(Petrucci et al.), a large international phase II study on retreatment with
Velcade in patients who had previously responded, demonstrating the efficacy
of Velcade as a retreatment option; and (3) a phase II trial (Dimopoulos
et al.) of Velcade as a second-line treatment in patients with relapsed or
refractory multiple myeloma - which showed an overall response rate of 83.7%.
Multiple myeloma, a cancer of the blood, is the second most common
haemtologic malignancy. Traditionally, multiple myeloma was associated with a
poor prognosis with a median survival of 3-5 years from diagnosis.
Although the disease remains incurable with conventional therapy, the
outlook for patients has improved in the last few years due to advances in
novel therapies, such as Velcade, which is increasingly being incorporated
into present-day treatment practices.
Notes to editors
About Velcade (bortezomib)
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 new 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. It is
licensed for use in combination with melphalan and prednisone in previously
untreated patients with multiple myeloma (i.e. the front line setting) who
are ineligible for high-dose chemotherapy and bone marrow transplant.
Janssen-Cilag is one of the world's leading research-based pharmaceutical
companies, with operations throughout the world.
The company is committed to discovering and delivering innovative
medicines for diseases of high unmet medical need and has introduced a range
of treatments that make an important difference to the lives of patients with
serious health conditions.
Key areas of activity include; psychiatry; neurology; oncology;
immunology, HIV; antibiotics; pain management; fungal diseases/dermatology;
gastroenterology and women's health.
Key products include Risperdal(R) (schizophrenia, bipolar disorder),
Risperdal(R) Consta(R) (schizophrenia) Concerta(R) XL (ADHD), Velcade(R)
(oncology), Prezista(R) & Intelence(R) (HIV), Stelara (psoriasis), Topamax(R)
(epilepsy, migraine), Doribax(R) (antibiotics), Daktarin(R) (anti-fungal),
Sporanox (anti-fungal), Durogesic(R) DTrans(R) (pain management), Pariet(R)
(gastroenterology), Cilest(R) and Evorel(R) (women's health).
Medicines developed by Janssen-Cilag are used to treat around 1,500
million patients worldwide every year.
Janssen-Cilag is part of the Johnson & Johnson family of companies, which
comprises around 250 operating companies throughout the world and employ
approximately 120,000 people in 57 countries. Johnson & Johnson is the
world's most comprehensive and broadly based manufacturer of health care
products and related services. More information can be found at
Velcade is co-developed by Millennium and Ortho Biotech Oncology Research
& Development, a unit of Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. Millennium is responsible for commercialization of
VELCADE in the U.S., Janssen-Cilag is responsible for commercialization in
Europe and the rest of the world. Takeda Pharmaceutical Company Limited and
Janssen Pharmaceutical K.K. entered into a co-promote agreement in May 2010
for VELCADE in Japan. VELCADE is approved in more than 90 countries and has
been used to treat more than 160,000 patients worldwide.
 Maria-Victoria Mateos et al. Bortezomib plus melphalan-prednisone
compared with Melphalan and Prednisone in previously untreated Multiple
Myeloma: Updated follow-up and impact of subsequent therapy in phase 111
VISTA trial. J Clin Oncol 2010;28 (13): 2259-66
 Janssen-Cilag International NV. Velcade 1 mg powder for solution for
injection. Summary of Product Characteristics, June 2010.
 Ludwig H, Viterbo L, Greil R, et al. Phase II study of Bortezomib,
thalidomide, and dexamethasone /- cyclophosphamide as induction therapy in
previously untreated multiple myeloma (MM): safety and activity including
evaluation of MRD; 15th Congress of the European Hematology Association 2010;
Jun 10-13; Barcelona, Spain. Abstr 0371
 Petrucci T, Blau I, Corradini P et al. Efficacy and safety of
retreatment with bortezomib in patients with multiple myeloma: interim
results from retrieve, a prospective international phase 2 study; 15th
Congress of the European Hematology Association 2010; Jun 10-13; Barcelona,
Spain. Abstr. 0377
 Dimopoulos M, Roddie H, Beksac M, et al. Randomized phase 2 trial of
bortezomib-dexamethasone (VD) versus VD plus cyclophosphamide or lenalidomide
in myeloma patients achieving stable disease after 4 cycles of VD as
second-line treatment; 15th Congress of the European Hematology Association
2010; Jun 10-13; Barcelona, Spain. Abstr 0366
For further information please contact: Jennifer Tear, Director, Communications and Public Affairs, Tel: +32-14-60-26-38, Mobile: +32-473-55-94-60, Email: JTear1 at its.jnj.com
Tags: Beerse, belgium, Janssen-Cilag, June 15