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Get a quick summary of key SPRYCEL efficacy, safety, and dosing information
77% of SPRYCEL patients achieved the cCCyR 12-month treatment milestone. 83% achieved the Year 5 treatment milestone.1
In newly diagnosed chronic phase CML patients:
Achieving MMR is an important milestone on a patient’s treatment path.5,6
After 5 years of follow-up, median time to MMR among responders was 9.3 months in the SPRYCEL arm (n=198) and 15 months in the imatinib arm (n=167)1
Baseline Hasford risk scores1,2
Patient transformations by year while on study10
SPRYCEL patients experienced no new transformations after Year 3 and continuing through Year 510
Imatinib patients experienced 2 new transformations after Year 3 and continuing through Year 510
94% of imatinib-treated patients on study did not transform to accelerated phase or blast crisis (245/260)1,10
All randomized patients who transformed while on study progressed to either accelerated phase or blast crisis.1
Treatment with SPRYCEL is associated with severe (NCI CTCAE Grade 3/4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
Dasatinib does not appear to be active against the T315I mutation, based on in vitro data.1
BCR-ABL=breakpoint cluster region-Abelson kinase; cCCyR=confirmed complete cytogenetic response; CI=confidence interval; CP=chronic phase; MMR=major molecular response; Ph+ CML=Philadelphia chromosome-positive chronic myeloid leukemia; RQ-PCR=real-time quantitative polymerase chain reaction.
*cCCyR was defined as CCyR (0% Ph+ metaphases) on 2 consecutive occasions at least 28 days apart.1,2
†MMR (at any time) defined as BCR-ABL ratios of ≤0.1% by RQ-PCR in peripheral blood samples standardized on the International Scale. These are cumulative rates representing minimum follow-up for the time frame specified.1,2
‡Inclusive of cCCyR in newly diagnosed adult patients with CP Ph+ CML by 1 and 5 years.1
§Adjusted for Hasford score and indicated statistical significance at a predefined nominal level of significance.1
||Includes cardiac failure acute, cardiac failure congestive, cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and left ventricular dysfunction.1
¶Includes erythema, erythema multiforme, rash, rash generalized, rash macular, rash papular, rash pustular, skin exfoliation, and rash vesicular.1
#Adverse reaction of special interest with <10% frequency.1
**Includes conjunctival hemorrhage, ear hemorrhage, ecchymosis, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemoptysis, intra-abdominal hematoma, petechiae, scleral hemorrhage, uterine hemorrhage, and vaginal hemorrhage.1