last updated 10/25/2013

Annotation of European Medicines Agency (EMA) label information
for dasatinib and ABL1, BCR

Testing required

Summary

The EMA European Public Assessment Report (EPAR) highlights information regarding the indication of Dasatinib (Sprycel) in patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia or acute lymphoblastic leukaemia.

Annotation

Excerpt from the Dasatinib (Sprycel) EPAR:

SPRYCEL is indicated for the treatment of adult patients with:

  • newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
  • chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate.
  • Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

This information is highlighted in the following sections:

Therapeutic indications, package leaflet: information for the user.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Dasatinib EMA drug label.

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Genes and/or phenotypes found in this label

No objects specified.

Label History