FDA Expands Bristol-Myers Squibb’s Dasatinib Tablets to Pediatric Patients

Bristol-Myers Squibb Co. (BMY) said the US Food and Drug Administration has expanded the indication for its Sprycel (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.

Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population, the pharmaceutical company said on Wednesday after the close of trading.

The approval, which was granted following priority review by the FDA, is based on data from the phase 2 study.

Sprycel is, however, associated with warnings and precautions including myelosuppression, bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, embryo-fetal toxicity and effects on growth and development in pediatric patients.

The efficacy of Sprycel tablets in combination with chemotherapy was evaluated in a single cohort of the phase 2, multicenter, single-arm CA180-372 study, which included 78 pediatric 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%, with a 95% confidence interval.

Of the 81 patients evaluated for safety, fatal adverse reactions occurred in three patients, or 4% while eight, or 10%, experienced adverse reactions leading to treatment discontinuation, including fungal sepsis, hepatotoxicity of graft versus host disease, thrombocytopenia, CMV infection, pneumonia, nausea, enteritis and drug hypersensitivity.