Download DRAFT #1 – Sept - CmlSociety.org

CANADIANS NEWLY DIAGNOSED WITH CHRONIC MYELOID LEUKEMIA NOW
HAVE NEW TREATMENT OPTION
SPRYCEL® approved by Health Canada as first-line treatment for life-threatening
blood cancer
MONTREAL, QUEBEC – July 22, 2011 – Canadians newly diagnosed with a lifethreatening blood cancer, chronic myeloid leukemia (CML) in chronic phase, now have a
new treatment option available to them. Health Canada has granted a notice of
compliance with conditions for SPRYCEL (dasatinib) as first-line treatment in patients
with chronic phase CML.
This authorization is based on an open-label, Phase 3 trial called DASISION, the results
of which were published last year in the New England Journal of Medicine. The trial
showed that patients with Philadelphia chromosome-positive (Ph+) CML in chronic
phase who received SPRYCEL attained higher and faster molecular and confirmed
complete cytogenetic response rates by 12 months compared to those who received
imatinib (marketed as Gleevec®). Recently updated 24-month data from the study show
similar efficacy trends.
“This is an important development for Canadians who are diagnosed with this disease
because it provides a new option for treatment and to improve quality of life for persons
with CML,” said Dr. Jeff Lipton, oncologist at Princess Margaret Hospital in Toronto.
Discovered and developed by Bristol-Myers Squibb, SPRYCEL is an oral therapy that
was first authorized by Health Canada in 2007 for use in patients with CML with
resistance or intolerance to prior imatinib therapy. “SPRYCEL has been a critical
treatment option in refractory CML for doctors and patients for almost five years and we
have learned first-hand the value it can bring to patients whose disease was
uncontrolled or who were intolerant to first-line therapy,” added Dr. Lipton. “Canadian
physicians will now be able to offer SPRYCEL once reimbursement is in place to newly
diagnosed patients as a first treatment option.”
“Great strides have been taken in the treatment of CML in recent years thanks to
medicines like SPRYCEL,” said Cheryl-Anne Simoneau, President and CEO of the CML
Society of Canada and herself living with CML. “We are pleased that there will now be a
new option for newly diagnosed patients. As patients we believe strongly in the value of
multiple treatment options.”
About chronic myeloid leukemia (CML)
CML is distinguished from the other types of leukemia by a genetic abnormality in the
white blood cells called the Philadelphia chromosome which promotes the growth of
leukemia cells and seems to be present in nearly 90 per cent of CML cases. The
Philadelphia chromosome is thought to be acquired after birth and is formed when two
chromosomes (9 and 22) switch some of their gene material, forming a new
chromosome. The Philadelphia chromosome contains an abnormal gene which
produces a protein which, in turn, causes the body to make too many abnormal white
blood cells. There is no known cause for the genetic change that causes CML. CML
primarily affects adults and accounts for about 15% of all leukemias. In Canada there are
approximately 460 new cases each year, or about 1 for every 100,000 persons.
SPRYCEL efficacy and safety
SPRYCEL is a once-daily orally administered multi-targeted inhibitor and works at
various sites within the abnormal cell. It has a unique mode of action which targets
multiple pathways associated with CML and reduces the activity of one or more proteins
responsible for the uncontrolled growth of the leukemia cells. This reduction allows the
bone marrow to resume production of normal red cells, white cells, and platelets.
SPRYCEL may be administered with or without food.
In the DASISION trial, the most frequently reported serious adverse reactions included
pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%) and pyrexia (1%).
About the DASISION study
DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) is an
open-label, randomized, Phase 3 international trial of SPRYCEL 100 mg taken once
daily vs. imatinib 400 mg taken once daily, in the treatment of newly diagnosed chronic
phase Ph+ CML. The study enrolled 519 patients; 259 patients were randomized to
receive SPRYCEL and 260 patients were randomized to receive imatinib. The primary
study endpoint was the rate of confirmed cytogenic response (CCyR) by 12 months.
Secondary endpoints included time to confirmed CCyR, major molecular response
(MMR) rate and time to MMR.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers
Squibb Company, a global biopharmaceutical company whose mission is to discover,
develop and deliver innovative medicines that help patients prevail over serious
diseases. Bristol-Myers Squibb Canada is a leading provider of medicines to fight
cancer, cardiovascular and metabolic disorders, infectious diseases (including
HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb
Company is listed on the New York Stock Exchange under the BMY symbol
(NYSE:BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montreal,
Quebec.
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For more information:
Sabrina Tremblay
Senior Manager Public Affairs
Bristol-Myers Squibb Canada
514-333-2463
[email protected]
Emmanuelle Vatel
HKDP Communications & Public Affairs
(514) 395-0375 ext. 234
[email protected]
SPRYCEL is a registered trademark of Bristol-Myers Squibb Company.