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Dasatinib Approved in EU for Pediatric Ph+ ALL

Jason M. Broderick and Gina Columbus
Published: Monday, Feb 11, 2019

Fouad Namouni, MD

Fouad Namouni, MD
The European Commission has approved dasatinib (Sprycel) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL), according to Bristol-Myers Squibb, the manufacturer of the TKI.

In November 2017, the FDA expanded the approval of dasatinib to include pediatric patients with Ph-positive CML-CP; the European Commission granted the same indication in July 2018.
Sprycel (dasatinib) Added to Standard Chemotherapy Demonstrates Three-Year Survival Benefit in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Posted December 9, 2017. Accessed February 11, 2019.

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