- The expansion approval is based on the CA180-372 (NCT01460160) P-II study results assessing Sprycel (qd, 60 mg/m @24 mos.) + CT in 78 patients with Ph+ ALLaged 2 to 10 yrs.
- The P-II CA180-372 study demonstrated as an effective treatment with EFS binary rate 64.1% in patients with newly diagnosed B-cell precursor Ph+ ALL
- Sprycel (dasatinib)is second-generation tyrosine kinase inhibitor, approved for use in children with one year of age and older with Ph+ (CMLCP)
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