Dasatinib Approved for Treatment of Certain Pediatric Patients – APhA submits compounding comments to FDA.

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Dasatinib Approved for Treatment of Certain Pediatric Patients – APhA submits compounding comments to FDA. – (866) 348-2889.

The FDA has approved dasatinib (Sprycel, Briston-Myers Squibb) tablets in combination with chemotherapy for the treatment of pediatric patients ≥1 year of age with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

The approval was based on findings from a single cohort of the phase II CA180-372 trial (NCT01460160), which demonstrated a 3-year event-free survival (EFS) binary rate of 64.1% (95% CI, 52.4%-74.7%) in 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL.

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