Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved an expanded indication for Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Previously, Sprycel was granted Priority Review and Orphan Drug Designation for this indication.
The safety and efficacy of Sprycel was studied in an open-label, non-randomized, dose-ranging trial and an open-label, non-randomized, single-arm trial involving a total of 97 pediatric patients with CP-CML. Of these patients, 51 had newly diagnosed CP-CML and 46 were resistant or intolerant to previous imatinib therapy.
In the studies, 91 of 97 patients received Sprycel 60mg/m2 once daily until disease progression or unacceptable toxicity. Efficacy endpoints included complete cytogenic response (CCyR), major cytogenic response (MCyR), and major molecule response (MMR). CCyR was achieved in 43.1% of newly diagnosed patients and 45.7% of patients with prior imatinib therapy at 3 months, 66.7% and 71.7% at 6 months, 96.1% and 78.3% at 12 months, and 96.1% and 82.6% at 24 months, respectively.
MCyR was achieved in 60.8% of newly diagnosed patients and 60.9% of patients with prior imatinib therapy at 3 months, 90.2% and 82.6% at 6 months, 98.0% and 89.1% at 12 months, and 98.0% and 89.1% at 24 months, respectively. MMR was achieved in 7.8% of newly diagnosed patients and 15.2% of patients with prior imatinib therapy at 3 months, 31.4% and 26.1% at 6 months, 56.9% and 39.1% at 12 months, and 74.5% and 52.2% at 24 months, respectively.
Treatment-related serious adverse events were observed in 14.4% of patients in the Sprycel arm, which included myelosuppression, headache, nausea, diarrhea, skin rash, extremity pain, and abdominal pain.
Sprycel, a tyrosine kinase inhibitor, is already indicated for chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib; and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
For more information call (800) 321-1335 or visit Sprycel.com.