mantle cell lymphoma | (bortezomib) is now approved in Canada to treat patients with Recently received a diagnosis of mantle

(bortezomib) is now approved in Canada to treat patients with
Recently received a diagnosis of mantle 



lymphoma
Patients with this aggressive form of blood cancer have a new option
Which significantly delays the evolution of the disease
Toronto, Ontario, April 15, 2015 – Janssen Inc. Today announced that health Canada has
Approved the use of VELCADE ® (bortezomib) as part of an association treatment
Intended for patients with previously untreated mantle lymphoma (LM) and not
Are not candidates for a stem cell transplant. Mantle lymphoma is a type of
Non-Hodgkin's lymphoma, which is a blood cancer that affects B lymphocytes. This form
Aggressive blood cancer is usually associated with a dark prognosis, survival rate
Median being three to four years1
.
In order to obtain the approval of VELCADE ® in the treatment of coat lymphoma cases
Newly diagnosed in Canada, the drug was the subject of a study in association with
With Rituximab, cyclophosphamide, doxorubicin and prednisone (also associated with
Called VcR-CAP). The results of the study showed significant benefits of treatment
Patients with LM using the VELCADE ®-based VcR-CAP Association, compared with the
To the current reference association treatment called R-CHOP (rituximab, cyclophosphamide,
Doxorubicin, vincristine and prednisone), which does not contain VELCADE ®.
2
In particular, the VcR-CAP Association scheme has significantly improved the survival of the
Without progression (SSP), the main criterion for evaluating the study. A Review committee
reported that the increase in the SSP was 59% (median of 24.7 P/R to
14.4 months; RR of 0.63; p < 0.001), while the study investigators reported a
96% SSP Increase (median 30.7 P/r to 16.1 months; RR of 0.51; p < 0.001) 3
. The
Evaluation criteria, including the delay before the progression of the disease and before the
Need to introduce another treatment, had almost doubled with the VcR-CAP scheme,
Compared to the R-CHOP4
.
LYM-3002 is a phase III, multicentre, International, randomized, prospective,
Open and controlled by active substance having focused on VELCADE ®. LYM-3002 was conducted
487 patients with a newly diagnosed LM who were not eligible for the
To a bone marrow transplant or to whom this intervention was not envisaged. The objective was to
To compare the efficacy and safety of VcR-CAP and R-CHOP5 Association treatments
.

Compared with the R-CHOP scheme, the VcR-CAP Association in the study was
associated with increased toxicity but maîtrisable6
. Overall, among patients receiving
The VcR-CAP Association, compared to those receiving the R-CHOP scheme, of the events
Serious adverse reactions (ARS) were reported in 38% p/r to 30% of patients and ARS of grade ≥ 3
Were reported in 93% p/r to 85% of patients. The rate of cessation of treatment due to EI
was 8% (VcR-CAP) P/r at 6% (R-CHOP), and the current drug-related death rate
of treatment was 2% compared to 3% 7
.
The approval of VELCADE ® as a first-line treatment against LM represents
An important step that highlights Janssen's commitment to patients with diabetes
B-cell cancers, such as LM and chronic lymphoid leukemia. The year 2008 a
marked the first indication of VELCADE ® against LM in patients who have undergone a
Relapse or have not responded to at least one previous treatment.
2
About VELCADE ®
VELCADE ® contains an active substance, bortezomib, which represents the first agent of a
Class of drugs called proteasome inhibitors. Present in all cells, the
Proteasome play an important role in the control of cellular function and growth,
As well as in how cells interact with other cells in their surroundings.
The bortezomib interrupts the normal activity of the cellular proteasome in a reversible manner,
Including cancer cells, thus halting growth and causing the death of Ci8
.
VELCADE ®, which has a predictable safety profile and a favorable benefit-risk ratio,
Can be used with patients ÂGÉS9
. Among the most common side effects of
VELCADE ®, we find fatigue, gastrointestinal adverse events,
Transient thrombocytopenia and Neuropathie10.
VELCADE ® was first approved in Canada under a notice of compliance with conditions
In January 2005 for the treatment of patients with multiple myeloma (MM) in relapse to
First-line treatment and do not respond to their most recent treatment.
VELCADE ® has also been approved for the treatment of patients suffering from relapsing LM or who
Have not responded to at least one previous treatment. In addition, in September 2008, VELCADE ®
been approved for treatment in patients with a previously untreated MM and
Who are not candidates for stem cell transplant.

In March 2012, another route of administration, or subcutaneous injection, approved in
treatment with VELCADE® of LM patients relapsed or who have not responded to in the
less previous treatment. In June 2013, VELCADE® was approved by Health Canada
in induction therapy reported as part of combination therapy recognized on the plan
medical patients of a MM untreated previously who are candidates for transplantation
stem cell (the studies have been conducted with VELCADE® administration
IV) 11.
VELCADE® is developed in collaboration with Millennium, the Takeda oncology company.
a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and Janssen
Pharmaceutical Companies. In Canada, it is Janssen Inc., which markets VELCADE®.
Approved in more than 90 countries, VELCADE® has been used to treat more of
550 000 patients around the world. Janssen is committed to developing way
continuous therapeutic solutions for treating cancer and other diseases
Hematologic.
About the LM
Lymphoma of the mantle is a rare and aggressive cancer of the blood that affects one
specific group of white blood cells (lymphocytes), called lymphocytes B12, 13. It counts
6% of the non-hodgkiniens lymphoma and occurs more often in men more than
in women, and usually after the age of 50 ans14. In Canada, it is estimated that approximately
480 adults have been diagnosed with LM in 201415. Patients are often diagnosed
LM at an advanced stage, and their median survival rate is three to four years16. People
who receive chemotherapy normally suffer a relapse within 12 to 18 mois17.
About Janssen Inc.
At Janssen Inc., Member of the Group of Janssen pharmaceutical companies, we we
use to meet some of the most important unmet medical needs in the
areas of Oncology, immunology, and neurosciences, infectious diseases and
vaccines, as well as cardiovascular and metabolic diseases. Driven by our
commitment to patients, we offer to the world of products, solutions and
innovative services.