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Regulatory News: Article   Printable Version 


Regulatory News Article
Sprycel® Gets Full Approval for Adults with Chronic Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted full approval to Bristol-Myers Squibb Company’s agent Sprycel® (dasatinib) for the treatment of adult patients in all phases of chronic myeloid leukemia (CML) who are resistant or intolerant to prior therapies including Gleevec® (imatinib mesylate).

Sprycel is an oral tyrosine kinase inhibitor reducing the activity of the BCR-ABL, SRC family, c-KIT, EPHA2, and PDGFR kinases.

Sprycel is also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.



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These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
© 1998-2007 OncoEd, Inc  All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.




   




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