The US Food and Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients, aged one year or more.
The expanded indication for Sprycel is in combination with chemotherapy. It was granted by the regulator following priority review based on the findings of the phase 2 study, called CA180-372.
The Bristol-Myers Squibb drug, which is a second-generation tyrosine kinase inhibitor, was evaluated in combination with chemotherapy for its efficacy in the treatment of newly diagnosed B-cell precursor Ph+ ALL, in the mid-stage trial, which included 78 pediatric patients.
At three years of treatment, the phase 2 trial showed an event-free survival (EFS) binary rate of 64.1%. Bristol-Myers Squibb defined EFS as the time from the start of treatment with its tyrosine kinase inhibitor to lack of complete response at the end of the third high-risk block, relapse, secondary malignancy or death from any cause.
The trial’s lead study author Stephen Hunger said: “The Phase 2 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 November 2017, the tyrosine kinase inhibitor was approved by the FDA for treatment of Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) in children one year of age and older.
Bristol-Myers Squibb hematology development lead Jeffrey Jackson said: “We recognize the urgency around developing and delivering therapies for children and young adults living with cancer, and today’s approval is an important example of our commitment to pediatric oncology.
“Building on our previous indication for children with Ph+ chronic myeloid leukemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL.”
For adult patients, the Bristol-Myers Squibb’s tyrosine kinase inhibitor was previously approved for the treatment of newly diagnosed Ph+ CML in chronic phase and Ph+ ALL with resistance or intolerance to prior therapy, among other indications.
The tyrosine kinase inhibitor functions by helping to lower the number of damaged white blood cells in the body. This reduction of damaged white blood cells may enable production of more normal blood cells.