Health Canada approves SPRYCEL as first-line treatment for life-threatening blood cancer

Canadians newly diagnosed with a life-threatening 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."