FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic... (rointestinal bleeding (4%) dyspnea (3%) ...)

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

Date:11/8/2007

rointestinal bleeding (4%), dyspnea (3%), sepsis (1%), diarrhea (2%), congestive heart failure (2%), and pericardial effusion (1%).

Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypocalcemia and hypophosphatemia were reported in patients with all phases of CML, but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML and Ph+ ALL. Elevations in transaminase or bilirubin were usually managed with dose reduction or interruption. Patients developing Grade 3/4 hypocalcemia during the course of SPRYCEL therapy often had recovery with oral calcium supplementation.

Full Prescribing Information is available at http://www.SPRYCEL.com.

About Bristol-Myers Squibb

For more than 40 years, Bristol-Myers Squibb has been committed to building a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists in Bristol-Myers Squibb's Research & Development organization are studying ways to improve current cancer treatments and identify better, more effective medicines for the future. Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

For more information regarding SPRYCEL, please visit http://www.SPRYCEL.com

* Gleevec(R) is a registered trademark of Novartis AG

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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic...(rointestinal bleeding (4%) dyspnea (3%) ...)