Bristol-Myers Squibb and Otsuka announced that the Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) labeling to include five-year efficacy and safety data in adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as seven-yer data in chronic phase Ph+ CML patients who are resistant or intolerant to prior therapy, including Gleevec (imatinib mesylate).

The DASISON Study (CA180-056) was a Phase 3 open-label, randomized, international trial of Sprycel 100mg once-daily (n=259) vs. imatinib 400mg once daily (n=260) in the treatment of newly-diagnosed CP Ph+ CML. The primary endpoint was confirmed complete cytogenetic response (CCyR) by 12 months; secondary endpoints included MMR at any time, time to major molecular response (MMR), and time to confirmed CCyR. By the time of final analysis, 61% of Sprycel and 62% of imatinib patients were still receiving treatment.

Study results showed 77% of patients treated with Sprycel and 66% of patients treated with imatinib met the primary endpoint of confirmed CCyR by 12 months (P=0.007). After the 5-year follow-up, median time to confirmed CCyR was 3.1 months for 215 Sprycel responders vs. 5.8 months for 204 imatinib responders. Long-term data confirmed that CCyR rates were higher in the Sprycel treatment group vs. imatinib treatment group (83% vs. 79%).

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The Dose Optimization Study (CA180-034) was an open-label, randomized study that assessed the safety and efficacy of Sprycel in CP Ph+ CML patients with resistance (n=497) or intolerance (n=173) to imatinib. Patients were randomly assigned to one of four treatment arms: 100mg once-daily (n=167), 50mg twice-daily (n=168), 140mg once-daily (n=167) and 70mg twice-daily (n=168).

Efficacy was seen across all Sprycel treatment groups and the once-daily schedule proved non-inferior to the twice-daily schedule for the primary efficacy endpoint (MCyR difference 2%; 955 CI -7 to 11%). The seven-year data showed 44% of study patients were known to be alive with an added 25% having unknown survival data. Among patients taking 100mg once-daily, nine patients transformed to accelerated or blast phase CML by seven years while on treatment. In addition, 63% of imatinib-resistant or -intolerant patients taking 100mg once-daily achieved MCyR at two years (95% CI: 56–71%).

Sprycel, a tyrosine kinase inhibitor, was initially approved by the FDA in 2006.

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