FDA Prioritizes Bristol Drug

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.





Novartis has additionally been developing a drug known as AMN107 that
is also designed to combat the drug resistance problem in Imatinib.



Besides Gleevec, interferon has also been used to treat CML, but
interferon also faces issues of drug resistance. CML is a slowly
progressing cancer of the blood and bone marrow. It progresses in
three stages: chronic, accelerated, and blast phases.



"The CML community has recognized that resistance is really a concern
for many patients," said Madeline Malia, a spokesperson for Bristol-
Myers Squibb. "There is an unmet need for those who have developed
resistance to current therapies, which is particularly a concern for
the accelerated and blast phases of CML, but also in the chronic
phase of CML."



Dasatinib was discovered by scientists within 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.