VIDAZA Demonstrates Unprecedented Overall Survival in Intermediate-2 and
Risk Myelodysplastic Syndromes, as Well as Acute Myeloid Leukemia
OAKVILLE, ON, Jan. 18 /CNW Telbec/ - Quebec patients with serious blood
cancers (intermediate-2 and high-risk myelodysplastic syndrome and
acute myeloid leukemia) now have publicly funded access to a new
innovative therapy, VIDAZA® (azacitidine). Following a priority review and subsequent positive
recommendation from the Conseil du medicament, patients now have the
potential to significantly extend survival.
"This decision by the Quebec government is exciting news for patients
and will make a huge difference in the way the disease is managed,"
said Chris Meyer, President, Aplastic Anemia and Myelodysplasia
Association of Canada (AAMAC). "We would like to see more Canadians
living with MDS and AML benefit from this treatment and we hope that
all other provinces follow in the footsteps of Quebec, Ontario, British
Columbia and Alberta which also have added VIDAZA to their provincial
VIDAZA is now reimbursed in Quebec for the treatment of adult patients
with intermediate-2 and high-risk myelodysplastic syndrome and acute
myeloid leukemia with 20-30% blasts and multi-lineage dysplasia who are
not eligible for hematopoietic stem cell transplantation. It represents
a new generation of cancer treatments in Canada because it is the first
drug that works via epigenetics to restore the normal function of genes
that regulate cell growth and development. VIDAZA is the first proven
treatment that alters the natural history of these diseases.
"This is without a doubt an important development in the way we treat
people with higher-risk MDS and AML," said Dr. Robert Delage, Associate
Professor in the Department of Medicine at l'Université Laval and Head
of le Centre universitaire d'hématologie et d'oncologie de Québec, at
the Hôpital de l'Enfant-Jésus in Québec City. "With VIDAZA we can treat
the underlying cause of the disease, rather than merely the symptoms by
affecting changes at the genetic level and offer patients, not only
freedom from frequent blood transfusions and an improved quality of
life, but also a proven chance to live longer."
Celgene is committed to helping to improve the quality of life of people
living with rare blood disorders in Canada and will continue to work
with officials in all provinces and territories to secure reimbursement
for VIDAZA through provincial drug plans.
MDS is a group of similar blood disorders that occur when blood cells in
the bone marrow do not mature and eventually suppress normal cell
development. An estimated 6,000 Canadians are living with MDS and
approximately 1,500 new MDS cases are diagnosed each year.
Mean survival rates can range from approximately six to nine months for
people with higher-risk MDS. For roughly 30 per cent of patients
diagnosed with this disorder, the abnormal bone marrow cells eventually
progress into acute myeloid leukemia (AML), a rapidly growing cancer of
the bone marrow cells.
VIDAZA is approved by Health Canada for the treatment of adult patients
with intermediate-2 and high-risk myelodysplastic syndrome (MDS) and
acute myeloid leukemia (AML) with 20-30% blasts and multi-lineage
dysplasia who are not eligible for hematopoietic stem cell
VIDAZA is believed to exert its antineoplastic effects by causing
hypomethylation of DNA and cytotoxicity of abnormal hematopoietic cells
in the bone marrow. DNA hypomethylation of aberrantly methylated genes
involved in normal cell cycle regulation, differentiation and death
pathways may result in gene re-expression and restoration of
cancer-suppressing functions to cancer cells. The cytotoxic effects of
VIDAZA cause the death of rapidly dividing cells, including cancer
cells that are no longer responsive to normal growth control
mechanisms. Non-proliferating cells are relatively insensitive to
AZA-001, the largest international, randomized, Phase III study ever
conducted in patients with higher-risk myelodysplastic syndrome (MDS)
was published in the journal The Lancet Oncology in February, 2009. The data indicate that VIDAZA (azacitidine)
demonstrated a significant extension of overall survival compared to
conventional care regimens (CCR) for patients with intermediate-2 and
high-risk MDS and AML with 20 to 30 percent bone marrow blasts.
The median overall survival for patients treated with VIDAZA (n=179) was
24.5 months compared to 15 months for those receiving CCR treatment
(n=179), an improvement of 9.5 months (p=0.0001). CCR includes best
supportive care, low-dose ARA-C, and standard chemotherapy. There was a
42 percent reduction in the risk of death (0.58 hazard ratio, 95% CI).
The two-year survival rate was nearly doubled at 50.8 percent for
patients receiving VIDAZA versus 26.2 percent for patients receiving
CCR (p=0.0001). The extension of survival was seen across the relevant
patient subgroups including those greater than 65 years of age and
those with poor cytogenetics, a poor prognostic factor. In addition, 34
percent of patients with AML as classified by the World Health
Organization saw a survival benefit.
In addition, 45 percent of patients achieved red blood cell transfusion
independence versus 11 percent of patients receiving CCR treatment
(p<0.0001) and 85.3 percent of patients treated with VIDAZA who were
red-blood-cell transfusion independent at baseline remained so.
Investigators aimed to treat patients until disease progression; the
median number of cycles of VIDAZA was nine.
Celgene Corporation is an integrated global biopharmaceutical company
engaged primarily in the discovery, development and commercialization
of novel therapies for the treatment of cancer and inflammatory
diseases through gene and protein regulation. For more information,
please visit the company's website at www.celgene.com.
VIDAZA is a registered trademark of Celgene Corporation.
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