Big day for Sprycel

[Guest guest]

After all the talk, it has now become official that Sprycel is indicated as

first-line treatment..............................

October 31, 2010 — " The US Food and Drug Administration (FDA) has approved an

expanded indication for dasatinib (Sprycel tablets; Bristol-Myers Squibb Co,

Ltd) for the first-line treatment of chronic-phase Philadelphia

chromosome-positive (Ph+) chronic myeloid leukemia (CML). Dasatinib previously

was reserved for use in patients with resistance or intolerance to prior therapy

including imatinib.

" 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, " said Elliott Sigal, MD, PhD, the executive vice

president, chief scientific officer, and president, research and development,

for Bristol-Myers Squibb, in a company news release.

" FDA approval was based on a priority review of data from the Dasatinib versus

Imatinib Study In Treatment-Naive CP-CML Patients (DASISION) open-label phase 3

head-to-head international trial (n = 519) of 100 mg dasatinib and 400 mg

imatinib, taken once daily. " More at website.

http://www.medscape.com/viewarticle/731670

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FYI,

Lottie Duthu