BMS’ second-generation TKI now registered to treat children with Ph+ leukaemia

Pharma News: Coping with a paediatric cancer diagnosis, including identifying the right treatment regimen, can take a significant physical and emotional toll on children and their families.

The Therapeutic Goods Administration (TGA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of paediatric patients newly diagnosed with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. 

Sprycel is the only second-generation tyrosine kinase inhibitor (TKI) approved for this patient population. 

The efficacy of Sprycel tablets in combination with chemotherapy was evaluated in a single cohort of the Phase 2, multicentre, single-arm CA180-372 study, which included paediatric patients with newly diagnosed B-cell precursor Ph+ ALL. At three years, the study demonstrated an event-free survival (EFS) binary rate of 64.1% (95% confidence interval [CI]: 52.4 to 74.7).

Acute lymphoblastic leukaemia is characterised by chromosomal abnormalities and genetic alterations involved in the differentiation and proliferation of lymphoid precursor cells. The most common childhood cancer, ALL represents 20% of all cancers diagnosed in persons aged less than 20 years, or more than 3,000 new cases each year. Only 3% of children who have ALL have the Ph+ subtype, which means they have a chromosome alteration that results in a specific mutation of the BCR-ABL gene.

In addition to this paediatric approval, Sprycel is approved for use in children with Ph+ chronic myeloid leukaemia (CML) in chronic phase (CP).