BRIEF—FDA approves dasatinib for pediatric patients with CML

The Food and Drug Administration granted regular approval for Sprycel (dasatinib) from Bristol-Myers Squibb for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.

Approval was based on data from 97 pediatric patients with chronic phase CML evaluated in two trials - a Phase I, open-label, non-randomized, dose-ranging study and a Phase II, open-label, non-randomized trial.

Fifty-one patients exclusively from the Phase II trial were newly diagnosed with chronic phase CML and 46 patients (17 from the Phase I trial and 29 from the Phase II trial) were resistant or intolerant to previous treatment with imatinib.

The majority of patients were treated with dasatinib tablets 60mg/m2 once daily. Patients were treated until disease progression or unacceptable toxicity.