Bristol-Myers Squibb Company has announced that the US Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML), as well as a powder for oral suspension (PFOS) formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.

“Today's 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. “Sprycel 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 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel in pediatric patients with CP-CML that are resistant to or intolerant of imatinib and in pediatric patients newly diagnosed with CP-CML. The efficacy endpoints included cumulative major cytogenetic response rate among imatinib-resistant or intolerant patients and 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 at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on June 5 and the 22nd Congress of the European Hematology Association on June 24.