Dasatinib Receives FDA Approval for Pediatric Ph+ Acute Lymphoblastic Leukemia

The FDA has approved dasatinib (Sprycel) tablets in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia.

Officials with the FDA have granted approval to dasatinib (Sprycel) 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.

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.

“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 <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/m

2

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.

For more information on this approval, continue reading on OncLive.