Annotation of U.S. Food and Drug Administration (FDA) label information
for dasatinib
and ABL1, BCR
Summary
The FDA-approved drug label for dasatinib (SPRYCEL) notes that it is intended for adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (Ph+ ALL) and resistance or intolerance to prior therapy.
Annotation
The FDA-approved drug label for dasatinib (SPRYCEL) states that the drug is indicated for treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia with resistance or intolerance to prior therapy. Dasatinib is a protein kinase inhibitor whose substrates include the BCR-ABL kinase encoded by the Philadelphia chromosome.
Excerpt from the dasatinib (SPRYCEL) drug label:
SPRYCEL is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase...adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib...[or] adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the dasatinib drug label.
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