Dasatinib Receives Priority Review for New CML Indications

The U.S. Food and Drug Administration (FDA) granted priority review to dasatinib, a tyrosine kinase inhibitor, for pediatric patients with chronic myeloid leukemia (CML).

The decision was based on results from the ongoing phase II CA180-226 study, which includes 113 pediatric patients in three cohorts:

  • 29 patients with CML who are imatinib-resistant or -intolerant received oral dasatinib 60 mg/m2
  • 51 patients with newly diagnosed CML received oral dasatinib 60 mg/msup>2
  • 33 patients with newly diagnosed CML received powder for oral suspension (PFOS) dasatinib 72 mg/msup>2

Among the imatinib-resistant and -intolerant patients, 90 percent achieved major cytogenetic response (MCyR), 83 percent achieved complete cytogenetic response (CCyR), and 55 percent achieved major molecular response (MMR).

Both the tablet and PFOS formulations produced high response rates: In both groups, 96 percent achieved MCyR, 94 percent achieved CCyR, and 70 percent achieved MMR. The estimated 48-month progression-free survival rate was more than 75 percent for imatinib-resistant and -intolerant patients, and more than 90 percent for those with newly diagnosed CML. The toxicity of dasatinib was consistent with that seen in adults, the researchers reported, and included thrombocytopenia, pyrexia, dyspnea, and diarrhea.

The FDA previously granted dasatinib approval for the treatment of newly diagnosed Philadelphia chromosome–positive (Ph+), chronic-phase CML in adults; Ph+ CML in patients who are intolerant to imatinib; and ALL.

Source: Bristol-Myers Squibb press release, July 20, 2017.