FDA approves label update for Sprycel (dasatinib) in Ph+ chronic myeloid leukemia- BMS/Otsuka

The FDA has approved an update to the product labelling of Sprycel (dasatinib), from BMS/Otsuka. The labeling now includes five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in CP Ph+ CML patients who are resistant or intolerant to prior therapy, including Gleevec (imatinib mesylate).

Approval was based partly on the DASISION study, in which 77% of patients treated with Sprycel vs. 66% of patients treated with imatinib achieved the primary endpoint of confirmed CCyR (defined as two consecutive assessments of CCyR at least 28 days apart) by 12 months. After five years of follow-up, median time to confirmed CCyR was 3.1 months in 215 Sprycel responders and 5.8 months in 204 imatinib responders7. In the long-term (by 5 years), confirmed CCyR rates were 83% Sprycel vs. 79% imatinib. Seven year data from a dose optimisation study was also included.