Sprycel, an oral BCR-ABL inhibitor, is currently approved by the FDA for the treatment of adults for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec. SPRYCEL is also approved for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
The data were published today in the New England Journal of Medicine and presented at the 46th Annual Meeting of the American Society of Clinical Oncology.
Dasision (Dasatinib versus Imatinib Study in Treatment-Naïve CML Patients) is an open-label, randomised, Phase 3 international trial of Sprycel 100mg taken once daily with no food restrictions vs. Gleevec 400mg taken once daily, in the treatment of newly diagnosed chronic phase CML. The primary study endpoint was confirmed CCyR by 12 months.
Other key endpoints were CCyR by 12 months, major molecular response (MMR) at any time, time to confirmed CCyR and MMR, progression-free survival and overall survival. The estimated rates of overall survival at 12 months are 97% for those subjects receiving Sprycel and 99% for those receiving Gleevec.
Hagop Kantarjian, chairman and professor of leukemia department at The University of Texas and lead author of the New England Journal of Medicine paper, said: “Current treatment guidelines state that achieving a complete cytogenetic response rate by 12 months is important because data suggest that there is an increased risk of disease progression in CML patients who do not attain this treatment goal.”
Bristol-Myers Squibb and Otsuka said that they were in the process of submitting the Dasision data to worldwide health authorities this year for the approval of Sprycel as a treatment for newly diagnosed adult patients with CML-CP.