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Outline
What is the generic name?
DASATINIB
What is the Trade Name for DASATINIB?
SPRYCEL
What are the Indications for DASATINIB?
- 1 INDICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with • Ph+ CML in chronic phase. • newly diagnosed Ph+ ALL in combination with chemotherapy. 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. (1 , 14) • adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) • adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) • pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) • pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)
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References: https://open.fda.gov/
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