The FDA has approved dasatinib (Sprycel) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
The US Food and Drug Administration (FDA) has approved dasatinib (Sprycel) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
An ongoing phase 2 clinical trial investigating dasatinib in combination with chemotherapy modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL served as the basis for the approval.
“Sprycel was first established as an important treatment option for appropriate pediatric patients last year, when it was approved for the treatment of children with Ph+ chronic myeloid leukemia,” said Jeffrey Jackson, PhD, development lead, hematology, Bristol-Myers Squibb, in a recent statement. “This latest milestone in Ph+ ALL reinforces our commitment to researching the potential of Sprycel in different types of pediatric leukemia and to providing this vulnerable population with access to potential new therapies.”
In the phase 2 trial, dasatinib was continually administered to 106 patients aged <18 years old starting at day 15 of induction chemotherapy. Cohort 1 evaluated for efficacy in 78 patients who were administered 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. If considered high-risk and based on minimal residual disease, patients were also administered stem cell transplants.
According to the results, all patients achieved complete remission, and patients with minimal residual disease (MRD) ≥0.05% at day 78 were eligible for hematopoietic stem cell transplantation (HSCT) in first remission. Patients with MRD 0.005% to 0.05% who were still MRD-positive following an additional 3 high-risk chemotherapy blocks were also eligible for HSCT.
Of the 106 patients, 19 met these criteria and were treated with HSCT [14.2% (n = 15)]. Two years of dasatinib treatment in combination with chemotherapy were administered to the other 91 patients.
The most common adverse reactions occurring in ≥15% included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. Serious adverse reactions were noted in ≥5% of patients involved pleural effusion (10%).
Dasatinib was initially approved in 2017 for the treatment of pediatric patients with Ph+ chronic myeloid leukemia in chronic phase.
A version of this article previously appeared on Rare Disease Report®’s sister publication, Oncology Live®.