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news.The European Commission has approved Bristol-Myers Squibb's drug Sprycel for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy, including Novartis' Gleevec.
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Sprycel is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) and lymphoid blast chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy.
“Sprycel was discovered and has been developed by Bristol-Myers Squibb scientists to help CML and Ph+ ALL patients who face a serious problem of resistance or intolerance to the current standard treatment,” said Beatrice Cazala, president for Europe, the Middle East and Africa at Bristol-Myers Squibb.
“With the approval of Sprycel in Europe, these patients now have an effective therapeutic option that can overcome treatment resistance and intolerance in certain cases.”
The European Medicines Agency reviewed the efficacy and safety of Sprycel based on the analysis of five phase II multi-center studies in patients with resistance or intolerance Gleevec in all phases of CML or Ph+ ALL.2 The studies were conducted in 33 countries and Sprycel was shown to have a predictable and manageable side-effect profile.