Sprycel (dasatinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Bristol-Myers Squibb Company. Sprycel (dasatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf. Revised February 2023. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	6
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.	2
SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Dasatinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Dasatinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Dasatinib
Sensitivity (+)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Dasatinib
Sensitivity (+)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Dasatinib
Sensitivity (+)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Dasatinib
Sensitivity (+)	BCR::ABL1	Acute Lymphoid Leukemia	Dasatinib
Sensitivity (+)	BCR::ABL1	Acute Lymphoid Leukemia	Dasatinib