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FDA Expands Indication for Dasatinib to Pediatric Patients With Ph+ ALL in Combination With Chemotherapy

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On January 2, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy. Dasatinib is the only second-generation tyrosine kinase inhibitor approved for this patient population. The approval, which was granted following Priority Review by the FDA, is based on data from the phase II CA180-372 trial.

In addition to this pediatric approval, dasatinib is approved for use in children 1 year of age and older with Ph+ chronic myeloid leukemia in chronic phase.

Three percent of children diagnosed with ALL have the Ph+ subtype, a chromosome alteration that results in a specific mutation of the BCR-ABL gene.

CA180-372    

The efficacy of dasatinib in combination with chemotherapy was evaluated in a single cohort of the phase II, multicenter, single-arm CA180-372 study, which included 78 pediatric patients with newly diagnosed B-cell precursor Ph+ ALL. At 3 years, the study demonstrated an event-free survival (EFS) binary rate of 64.1% (95% confidence interval [CI] = 52.4–74.7). 

Of the 81 patients evaluated for safety, fatal adverse reactions occurred in 3 patients (4%), and 8 (10%) experienced adverse reactions 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 adverse reactions (incidence ≥ 10%) were pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections (bacterial, viral, and fungal), hypersensitivity, vomiting, renal insufficiency, abdominal pain, and musculoskeletal pain.

Dasatinib is associated with the following warnings and precautions: myelosuppression, bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, embryofetal toxicity, and effects on growth and development in pediatric patients.

View the full prescribing information for dasatinib.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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