FDA Advisory Committee Recommends Accelerated Approval of Dasatinib

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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® (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