FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML

On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral suspension formulation of dasatinib. The application is under priority review, with an action date of November 9, 2017.

“[This] news reinforces our commitment to addressing the unique and often unmet needs of pediatric oncology patients, including children with newly diagnosed and imatinib-intolerant or -resistant CML,” said Murdo Gordon, Executive Vice President and Chief Commercial Officer, Bristol-Myers Squibb. “Dasatinib also has the potential to be the first drug in its class approved for pediatric use with an oral solution.”

The sNDA includes data from CA180-226, an ongoing phase II, open-label, nonrandomized trial studying dasatinib in pediatric patients with chronic-phase CML that is resistant to or intolerant of imatinib and in pediatric patients newly diagnosed with chronic-phase CML. The efficacy endpoints included the cumulative major cytogenetic response rate among patients with imatinib-resistant or -intolerant disease and the cumulative complete cytogenetic response rate in newly diagnosed patients. Additional efficacy measures were time to and duration of response, progression-free survival, overall survival, and major molecular response. Safety was also assessed.

Data from this study were shared in oral presentations by Gore et al at the 2017 ASCO Annual Meeting (Abstract 10511) and by Zwaan et al the 22nd Congress of the European Hematology Association (Abstract S422).

About Dasatinib

Dasatinib first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome–positive CML in chronic phase that was resistant or intolerant to prior therapy, including imatinib. At that time, dasatinib was also approved for adults with Philadelphia chromosome–positive acute lymphoblastic leukemia that was resistant or intolerant to prior therapy. Dasatinib is approved and marketed worldwide for these indications in more than 60 countries.

Dasatinib is also an FDA-approved treatment for adults with newly diagnosed chronic-phase Philadelphia chromosome–positive CML (since October 2010)—it received accelerated FDA approval for this indication. This indication is approved in more than 50 countries.

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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