Bristol-Myers Squibb Co. said the FDA accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel.
The application has an action date of Nov. 9.
The sNDA includes data from CA180-226 (NCT00777036), an ongoing phase II, 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.
Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase who are resistant or intolerant to prior therapy including imatinib.
At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.
Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. This indication is approved in more than 50 countries.
