Bristol-Myers Squibb and Otsuka Pharmaceutical are collaborative partners in the commercialisation of Sprycel in the US, Japan and major European countries. Sprycel was discovered and developed by Bristol-Myers Squibb.
The approval was based on results from the DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) open-label, randomised, Phase 3 international trial of Sprycel 100 mg taken once daily vs. imatinib 400 mg taken once daily, in the treatment of newly diagnosed chronic phase Ph+ CML.
The study enrolled 519 patients; 259 patients were randomised to receive Sprycel and 260 patients were randomised to receive imatinib.
Bristol-Myers Squibb said that Sprycel demonstrated superior efficacy with higher and faster molecular and confirmed cytogenetic response rates compared to imatinib by 12 months in newly diagnosed CP-CML patients.
Around 77% [95% CI: 71.2 – 81.8] of SPRYCEL patients vs. 66% [95% CI: 60.1 – 71.9] of imatinib patients achieved the primary endpoint of confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 12 months (p=0.007).
Bristol-Myers Squibb R&D executive vice president, chief scientific officer and president Elliott Sigal said that the FDA approval of Sprycel as a first-line treatment for chronic phase CML builds on their commitment to advancing care in hematologic malignancies.
"Patients now have an option that has both improved response over imatinib, the current standard of care, and offers a once-daily dosing convenience with no fasting requirements," Sigal said.