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.
SPRYCEL is a registered trademark of Bristol-Myers Squibb Company.
