BMS’s Sprycel (dasatinib) sBLA Receives Positive Response from the US FDA
BMS’s Sprycel (dasatinib) sBLA Receives Positive Response from the US FDA
Shots:
- This sBLA involves (Sprycel + CT) for the treatment of pediatric patients (≤17yrs) newly diagnosed with Philadelphia chromosome +ve ALL
- The application is based on the ongoing P-II CA180-372 (NCT01460160) trial evaluating (Sprycel + CT) modeled on a Berlin-Frankfurt-Munster high-risk backbone in patients with Ph+ ALL
- Expected Action date by FDA is Dec 29, 2018. Though, Sprycel received expanded approval from FDA and EU for Ph+ CML in Nov 2017 and July 2018