FDA approves new Sprycel indication

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FDA approves new Sprycel indication

By Sandra Levy - 01/03/2019
Bristol-Myers Squibb has received the Food and Drug Administration’s clearance for an expanded indication for Sprycel (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive, or Ph+ acute lymphoblastic leukemia, or ALL in combination with chemotherapy.

Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population, according to the company.

In addition to this pediatric approval, Sprycel is approved for use in children one year of age and older with Ph+ chronic myeloid leukemia, or CML in chronic phase, or CP.

“We recognize the urgency around developing and delivering therapies for children and young adults living with cancer, and today’s approval is an important example of our commitment to pediatric oncology. Building on our previous indication for children with Ph+ chronic myeloid leukemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL,” Bristol-Myers Squibb's development lead of hematology, Jeffrey Jackson said.

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