Dasatinib Granted Approval for Pediatric Indication

The FDA expanded the indication of dasatinib, a second-generation tyrosine kinase inhibitor, to include the treatment of pediatric patients (≥1 year of age) with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphocytic leukemia (ALL).

The approval was based on results from the phase II CA180-372 trial, which enrolled 106 children with newly diagnosed, Ph-positive ALL to received dasatinib plus chemotherapy. Among the 78 patients who were evaluable for efficacy, the three-year event-free survival rate was 64.1 percent.

Of the 81 patients included in the safety analysis, three (4%) experienced a grade 5 AE. Eight patients (10%) experienced AEs leading to treatment discontinuation, including fungal sepsis, hepatotoxicity of graft-vs.-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis and drug hypersensitivity. The most common serious AEs (occurring in ≥10% of patients) included pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, and infections.

Dasatinib received priority-review designation for this indication.

Source: Bristol-Myers Squibb press release, January 2, 2019.