Paris (ots/PRNewswire) – Bristol-Myers Squibb today announced that SPRYCEL(R) (dasatinib) 100mg once daily received Marketing Authorization from the European Commission for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) Chronic Myelogenous Leukaemia in Chronic Phase (CML-CP). Sprycel is the first new approved treatment in the E.U. with superior efficacy vs. imatinib in this indication since 2001. The authorization is based on results from the DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) open-label, Phase 3 trial, which were presented as a late-breaking abstract at the 46th Annual Meeting of the American Society of Clinical Oncology, during the Best Abstracts section of the Presidential Symposium at the 15th Congress of the EHA and published in The New England Journal of Medicine in June 2010.[1] The trial is ongoing and further data will be required to determine long-term outcomes.
“The Marketing Authorization by the European Commission is an important development for CML patients and their physicians in Europe who now have an option that has both improved response over imatinib and offers a once-daily dosing convenience with no fasting requirements,” said Elliott Sigal, Executive Vice President, CSO & President, R&D, Bristol-Myers Squibb. “Data from the DASISION trial demonstrated that newly diagnosed patients with Philadelphia chromosome positive CML in chronic phase who received dasatinib attained higher and faster molecular and confirmed complete cytogenetic response rates by 12 months compared to imatinib.”
Lead DASISION investigator Professor Michele Baccarani, University of Bologna, Italy commented: “The profile of CML, one of the four most common types of leukaemia, has changed dramatically in recent years with the introduction of targeted therapies; its prevalence is growing as patients live longer. The European Marketing Authorization and results of the DASISION study confirm the role of dasatinib as an option in the frontline treatment of Philadelphia positive chronic myelogenous leukaemia.”
Dasatinib Demonstrated Superior Response Rates Compared to imatinib[1]
In the DASISION study, dasatinib demonstrated superior efficacy with higher and faster molecular and confirmed cytogenetic response rates compared to imatinib by 12 months in newly diagnosed CP-CML patients. Seventy-seven percent [95% CI: 71- 82] of dasatinib patients vs. 66% [95% CI: 60 - 72] of imatinib patients achieved the primary endpoint of confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 12 months (p=0.007). Median time to confirmed CCyR was 3.1 months in 199 dasatinib responders and 5.6 months in 177 imatinib responders. Median time to major molecular response[iii] (MMR) was 6.3 months in 135 dasatinib responders and 9.2 months in 88 imatinib responders. MMR at anytime was higher for dasatinib patients (52% [95% CI: 45 - 58]) versus imatinib (34% [95% CI: 28 - 40]), p
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