The Food and Drug Administration (FDA) approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients aged ≥1 year with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

Sprycel, a second generation tyrosine kinase inhibitor, is already approved to treat: Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) in children and adults; chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib in adults; and Ph+ ALL with resistance or intolerance to prior therapy in adults.

“As treatments have advanced in recent years, we’ve seen improvements in outcomes for pediatric patients with Ph+ ALL overall, but there remains a need for additional options,” said Stephen Hunger, MD, lead study author, chief of the division of oncology and director of the Center for Childhood Cancer Research at Children’s Hospital of Philadelphia, in a press release. “The phase II CA180-372 trial was particularly informative because it was designed to limit the use of cranial irradiation and stem cell transplant. In the study, Sprycel plus chemotherapy demonstrated a three-year event-free survival benefit. These results show that Sprycel is an effective medication for physicians to consider for children and adolescents with Ph+ ALL.”

In the phase II study, 106 patients aged younger than 18 years old were treated with continuous daily dasatinib starting at day 15 of induction chemotherapy. The 78 patients evaluated for efficacy in cohort 1 received dasatinib at 60 mg/m2 daily for up to 2 years in combination with a backbone chemotherapy regimen of the AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol. Additionally, patients were assigned to receive stem cell transplant based on minimal residual disease if they were considered high-risk.