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FDA Accepts sBLA for Dasatinib in Pediatric Patients With Newly Diagnosed Ph-Positive ALL

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The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL). The FDA action date is December 29, 2018.

The application is based on data from CA180-372, an ongoing phase II trial evaluating the addition of dasatinib to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph-positive ALL.

About Dasatinib

Dasatinib first received FDA approval in 2006 for the treatment of adults with Ph-positive chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy, including imatinib. At that time, dasatinib also received FDA approval for adults with Ph-positive ALL who are resistant or intolerant to prior therapy. Dasatinib is approved and marketed for these indications in more than 60 countries.

Dasatinib is also an FDA-approved treatment for adults with newly diagnosed Ph-positive CML-CP and is approved for this indication in more than 50 countries. Both the FDA and the European Commission approved the expansion of dasatinib’s indication to include pediatric patients with Ph-positive CML-CP (in November 2017 and July 2018, respectively).

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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