FDA Panel Backs Bristol Drug

June 3, 2006

By Althea Chang

TheStreet.com Staff Reporter

6/2/2006 5:15 PM EDT

Click here for more stories by Althea Chang

The Bristol-Myers Squibb (BMY:NYSE - commentary - research - Cramer's

Take) cancer drug Sprycel got the nod from an advisory panel to the

Food and Drug Administration for the treatment of certain types of

rare blood cancers.

According to a drug advisory committee's review of clinical trial

data, Sprycel is effective for certain types of chronic myeloid

leukemia, as well as a type of acute lymphoblastic leukemia in

patients who couldn't tolerate or didn't respond to prior drug

therapies, including Novartis' (NVS:NYSE ADR - commentary - research -

Cramer's Take) Gleevec, a standard treatment for the diseases.

Because of the strength of the trial results, the committee believes

Sprycel should be granted accelerated approval for use against chronic

myeloid leukemia. The committee's decision on Friday to recommend that

the full FDA clear the drug was based on an early phase I study

conducted to determine the safest dosages of the drug and five phase

II studies on the safety and effectiveness of Sprycel. A total of 551

patients were enrolled and treated.

While the FDA doesn't have to agree with the advisory committee's

recommendation, it usually follows the suggestions of its panels.

Documents posted by the FDA on its Web site did say that 99% of

patients who took Sprycel had at least one negative side effect,

including fluid retention, anemia, bleeding, gastrointestinal side

effects or heart attacks. In addition, six central nervous system

hemorrhages occurred, five of which were fatal.

Chronic myeloid leukemia is diagnosed in about 4,300 people each year

in the U.S. and accounts for 14% of adult leukemia cases, according to

the FDA. There is currently no approved treatment for the

Gleevec-resistant version of the disease.

Sprycel, also known by the name dasatinib, has already been granted

priority review status by the FDA, a designation given to drugs that

could be a significant improvement from existing therapies. The FDA is

expected to make its decision by June 28.

Bristol-Myers Squibb's shares rose 12 cents, or 0.5%, to $25.27.

Recommended Posts