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FDA Advisory Committee Recommends Accelerated Approval of Dasatinib, Treatment for Adults With Chronic Myeloid Leukemia

PRINCETON, N.J., June 2 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee voted in favor of recommending accelerated approval of dasatinib, the company's investigational compound, for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including Gleevec(R) (imatinib mesylate). Phases of CML include chronic, accelerated, lymphoid blast and myeloid blast. The Committee also recommended full approval of dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to imatinib. While the FDA is not bound by the committee's recommendations, they generally follow the advice of the panel.

When Bristol-Myers Squibb submitted its new drug application (NDA) for dasatinib, the FDA granted a priority review -- a status reserved for products that address unmet medical needs. Based on the priority review, the FDA's action date for the NDA is June 28, 2006.

"Bristol-Myers Squibb is dedicated to conducting research and to developing therapies designed to aid in the fight against serious diseases with unmet medical needs, such as leukemias and other malignancies," said Elliott Sigal, chief scientific officer, and president, Pharmaceutical Research Institute, Bristol-Myers Squibb. "We are committed to working with the FDA to support the potential approval of dasatinib."

Dasatinib was discovered and is being developed by scientists within Bristol-Myers Squibb.

The FDA Oncologic Drugs Advisory Committee based their recommendation on review of data from the dasatinib clinical development program. Data included safety and efficacy results from five international, multi-center Phase II trials, together with other supportive data. Phase II trials analyzed data from all phases of CML or Ph+ ALL in patients resistant or intolerant to prior therapy.

About CML and Ph+ ALL
CML is a cancer of the blood and bone marrow that usually occurs during or after middle age and rarely occurs in children. The incidence of resistance increases with the number of years on treatment and severity of disease.

Ph+ ALL is a rapidly progressive cancer of the blood and bone marrow that usually occurs in adults. Patients with advanced Ph+ ALL generally develop resistance more rapidly than CML patients, including those in blast phase (an average of 2 months versus 10 months, respectively).

Source: Bristol-Myers Squibb

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