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news.Bristol-Myers Squibb has received marketing authorization from the European Commission for Sprycel (dasatinib) 100mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia in chronic phase (CML-CP).
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Dasatinib, an oral BCR-ABL inhibitor, was initially approved in November 2006 by the European Commission 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 imatinib.
The authorisation is based on results from an open-label DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) Phase III trial which was designed to evaluate dasatinib versus imatinib in treatment-naïve CP-CML patients.
In the Phase III, dasatinib demonstrated superior efficacy with higher and faster molecular and confirmed cytogenetic response rates compared to imatinib by 12 months in patients with newly diagnosed CP-CML.
The Phase III enrolled 519 patients who were randomised to receive dasatinib 100mg taken once daily or imatinib 400mg taken once daily.
Bristol-Myers Squibb R&D CSO and president Elliott Sigal said 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.