Sprycel Receives New Pediatric Indication
December 21, 2018 – The U.S. FDA has approved a new pediatric indication for Sprycel® (dasatinib) tablets, manufactured by Bristol-Myers Squibb. The drug is now approved for use in combination with chemotherapy as a first-line therapy for children as young as one year of age who have Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
Up to 3% of children diagnosed with ALL are Ph+. The disease presents in the same manner as other forms of ALL, and can only be identified using diagnostic tests that search for the Philadelphia chromosome mutation. Survival rates with chemotherapy alone have historically been poor – only 30% for children diagnosed with Ph+ ALL versus more than 85% for children diagnosed with other forms of ALL. Tyrosine kinase inhibitors such as Sprycel have improved survival rates for Ph+ ALL in children to approximately 70%.
In a clinical study, 64.1% of pediatric patients had event-free survival lasting at least three years when treated with Sprycel. Fatal adverse reactions occurred in 4% of patients, and 10% of patients experienced adverse reactions that led to discontinuation of treatment. The median duration of therapy was 24 months. Recommended dosing for children is based on weight, with the dose recalculated every three months to account for changes in the child’s weight. Taken once daily by mouth, Sprycel should be swallowed whole and not cut, crushed, or chewed.
Sprycel carries a second pediatric indication to treat Ph+ chronic phase myeloid leukemia (CML) in children as young as one year of age. It is also indicated to treat certain adult patients who have Ph+ CML or ALL.