FDA Expands Dasatinib’s Approval to Pediatric Ph-Positive ALL

The U.S. Food and Drug Administration (FDA) expanded the approval of dasatinib to include the treatment of pediatric patients (≥1 year of age) with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphocytic leukemia (ALL) in combination with chemotherapy.

The approval is based on results from the phase II, multicenter, single-arm CA180-372 study, which included 78 pediatric patients with newly diagnosed B-cell precursor Ph-positive ALL. All patients received dasatinib (a second-generation tyrosine kinase inhibitor) with chemotherapy. At three years, researchers reported an event-free survival rate of 64.1 percent (95% CI 52.4-74.7).

Of the 81 patients evaluated for safety, fatal adverse events (AEs) occurred in three patients. Eight patients experienced AEs leading to treatment discontinuation, including fungal sepsis, hepatotoxicity of graft-versus-host disease, thrombocytopenia, cytomegalovirus infection, pneumonia, nausea, enteritis, and drug hypersensitivity.

The most common serious AEs (≥10%) were pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections (bacterial, viral, and fungal), hypersensitivity, vomiting, renal insufficiency, and abdominal and musculoskeletal pain.

Dasatinib was previously approved for the treatment of adults and children with Ph-positive chronic-phase chronic myeloid leukemia, as well as adults with Ph-positive ALL.

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