Adult Clinical Trials
Has SPRYCEL® (dasatinib)
been studied in adults in clinical trials?
Your doctor has chosen SPRYCEL because he or she believes it is the right treatment for you.
SPRYCEL is approved for use in newly diagnosed adult patients with Ph+ CML in chronic phase based on a head-to-head clinical trial of SPRYCEL compared to imatinib.
How many patients
been treated with SPRYCEL?
Since its introduction in 2006, over
45,000 patients have been treated
*Across all indications. SPRYCEL received initial approval in June 2006 for treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including imatinib; the effectiveness of SPRYCEL was based on treatment response that was seen in both the blood and bone marrow. SPRYCEL also received approval at that time for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
How was SPRYCEL studied?
SPRYCEL was studied in people who were newly diagnosed with Ph+ CML in chronic phase—in direct comparison with another TKI called imatinib.
The main goal of the trial was to see the effect of SPRYCEL and imatinib on cCCyR by one year.
Another goal of the study was to measure MMR.
Confirmed Complete Cytogenetic Response (cCCyR)
A cytogenetic response can occur in the bone marrow, as well as in the blood. A confirmed Complete Cytogenetic Response means that there were no signs of bad cells in 2 bone marrow tests.
Major Molecular Response (MMR)
This is a very sensitive test that can detect other bad cells in the bone marrow. A Major Molecular Response means that the amount of BCR-ABL protein is very low.