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FDA Panel Backs Bristol Drug

The committee recommends that the agency approve Sprycel.


Bristol-Myers Squibb

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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


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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.