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FDA Accepts Application for Dasatinib for Pediatric Ph+ ALL

Jason M. Broderick @jasoncology
Published: Thursday, Aug 30, 2018

The FDA has accepted a supplemental biologics license application (sBLA) for dasatinib (Sprycel) for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).1

In November 2017, the FDA approved dasatinib for the treatment of pediatric patients with Ph+ chronic myeloid leukemia in chronic phase.

References

  1. U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. Posted August 30, 2018. Accessed August 30, 2018. https://bit.ly/2LLh1Ko?rel=0" .
  2. 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 August 30, 2018. https://bit.ly/2MEcNta?rel=0" .

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