Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
The sBLA contains data from the Phase 2 CA180-372 trial evaluating Sprycel as an add-on to chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
Sprycel, a tyrosine kinase inhibitor, was initially approved in 2006 for the treatment of adults with Ph+ chronic myeloid leukemia (CML) and those with Ph+ CML in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. It is also indicated to treat adults with newly diagnosed Ph+ CML-CP.
Sprycel is available as 20mg, 50mg, 70mg, 80mg, 100mg, and 140mg strength tablets.
The Prescription Drug User Fee Act (PDUFA) date has been set for December 29, 2018.
For more information call (800) 321-1335 or visit BMS.com.