Updating Info on CML Rx

Sprycel receives updated labeling from FDA

/ Author:  / Reviewed by: Dominique Brooks, M.D Beth Bolt, RPh

(RxWiki News) Chronic myeloid leukemia (CML) was once a dire diagnosis. Now the disease can be treated successfully in most people. The disease has to be treated over many years to be kept under control.

The US Food and Drug Administration (FDA) has changed the product labeling on the medication Sprycel (dasatinib).

The labeling now includes three-year efficacy and safety data in patients newly diagnosed with Philadelphia chromosome-positive (Ph+) CML in the chronic (initial) phase of the disease.  

The agency also updated five-year data in chronic phase Ph+ CML patients who are resistant or intolerant to Gleevec (imatinib).

"Learn when it’s time to change medications."

Sprycel is currently approved to treat all phases of Ph+ CML that's become resistant to or intolerant of imatinib. Additionally, it is used to treat acute lymphoblastic leukemia (ALL) that is resistant to or intolerant of previous treatment.

"We are fortunate to be living at a time when, for many patients, CML can often be managed as a chronic disease, thanks to treatments like Sprycel," said Greg Stephens, executive director of the National CML Society.

"As patients continue to benefit from these treatments, understanding their safety and effectiveness over time becomes increasingly important and may help inform the decisions of healthcare providers as to which therapy they choose," Stephens said in a news release.

The labeling change is based on three-year data from the ongoing international study DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CML Patients). 

Sprycel has demonstrated itself to be more effective than Gleevec in two key measures: cytogenetic response (CCyR), which means fewer defective chromosomes are seen than when the patient was diagnosed, and major molecular response (MMR), which indicates very low amounts of defective chromosomes.

In the DASISION trial, by 12 months, 77 percent of CML patients taking Sprycel had achieved CCyR compared to 66 percent of patients taking imatinib.

After three years, confirmed CCyR rates continued to increase (83 percent of Sprycel patients versus 77 percent of imatinib patients).

MMR rates were also higher in Sprycel-treated patients than in those who took Gleevec.

Sprycel is an oral medication, marketed by Bristol-Myers Squibb, that costs about $9,300 for a 30-day supply.

Review Date: 
June 21, 2013
Last Updated:
August 12, 2013