1 INDICATIONS AND USAGE
SPRYCELÒ (dasatinib) is indicated for the treatment of adults with
- newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of SPRYCEL is based on cytogenetic response and major molecular response rates [see Clinical Studies (14.1)]. The trial is ongoing and further data will be required to determine long-term outcome.
- 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL.
PATIENT INFORMATION
What is SPRYCEL?
SPRYCEL is a prescription medicine used to treat:
• adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
• adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including Gleevec® (imatinib mesylate).
• adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment.
• children 1 year of age and older with Ph+ CML in chronic phase.
• children 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.