FDA Prioritizes Bristol Drug

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Cancer treatment Dasatinib will receive a faster review from U.S.

regulators.

March 7, 2006

Bristol-Myers Squibb said Tuesday that the U.S. Food and Drug

Administration has accepted a new drug application for Bristol's

cancer drug Dasatinib and has granted the leukemia treatment a

priority review for accelerated approval.

The FDA will have six months from the submission date—until June 28—to

take action.

The Princeton, New Jersey-based company developed the investigational

compound to treat two forms of leukemia: chronic myelogenous leukemia

(CML), as well as Philadelphia chromosome-positive acute lymphoblastic

leukemia.

The two forms of the disease lead to an excess of white blood cells

being produced in the bone marrow. The drug is aimed at patients who

show resistance or intolerance to other forms of therapy.

Many patients with chronic myeloid leukemia take Imatinib, also known

as Gleevec, to treat the disease but later develop resistance to the

drug. Novartis Pharmaceuticals of East Hanover, New Jersey, received

approval from the FDA for Gleevec in December 2003.

Bristol-Myers Squibb Laboratories. Researchers have already conducted

a phase I study of Dasatinib and presented their findings during

December 2004 at a meeting of the American Society of Hematology (ASH).

They gave the drug to patients who no longer were responding to

Imatinib and found that 86 percent showed a complete hematological

response within nine months and 28 percent exhibited a major

cytogenetic response. Another phase I study was presented in May 2005.

Results of a phase II study were presented last December at another

ASH meeting.

Despite the encouraging news about the FDA review, shares of

Bristol-Myers Squibb fell $0.16 to $22.65 in recent trading, following

the broader market lower. Shares of Novartis dropped $0.35 to $53.63.