FDA: Proposed Bristol-Myers Drug Appears To Slow Leukemia

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FDA: Proposed Bristol-Myers Drug Appears To Slow Leukemia

June 1, 2006: 10:55 a.m. EST

By Corbett Dooren Of DOW JONES NEWSWIRES ATLANTA -(Dow )-

The U.S. Food and Drug Administration said Thursday a proposed drug

from Bristol-Myers Squibb Co. (BMY) appears to slow the progression of

certain types of leukemia in patients who failed other treatments

including Novartis AG's (NVS) Gleevec, based on preliminary clinical

studies.

The FDA posted its review of the drug, dasatinib, on its Web site

Thursday, a day before an outside panel of medical experts is set to

make recommendations about whether the agency should approve the drug.

The FDA's oncology advisory panel meeting will be held in Atlanta to

coincide with the American Society of Clinical Oncology's annual

meeting, which brings together top cancer researchers and experts.

Specifically, Bristol-Myers is seeking FDA approval for dasatinib to

treat patients with chronic myeloid leukemia, or CML, who have failed

treatment with other therapies such as Gleevec and the treatment of

adults with Philadelphia chromosome-positive acute lymphoblastic

leukemia and lymphoid blast chronic myeloid leukemia who have failed

other treatments.

Bristol-Myers submitted four Phase II studies looking at 551 patients

with different types of leukemia. All of the studies show dasatinib,

which the company has proposed selling under the brand name Sprycel,

either halted the progression of the disease or made it undetectable

in several patients. The drug showed a response rate in a range of 31%

to 74% of patients depending on which type of leukemia they had.

However, the patients haven't been followed long enough to determine

whether treatment with dasatinib improves overall survival.

The studies also showed that almost all patients suffered from an

adverse event, such as diarrhea, nausea and vomiting, that likely was

caused by the drug. About 66% of patients suffered more serious

problems including fluid retention, a worsening of underlying blood

problems such as anemia and, in some cases, cardiac problems.

One of the issues the panel will consider is whether a lower starting

dose of dasatinib should be recommended in order to lower the rate of

adverse events. The panel also will be asked whether the company has

submitted enough data " to recommend dasatinib for the imatinib

(Gleevec) intolerant population, " the FDA said in a memo.

When considering cancer drugs, the FDA sometimes accepts earlier Phase

II studies rather than larger Phase III studies it typically requires

most companies to submit with drug-approval applications. The FDA can

grant so-called accelerated approval of a drug based on Phase II

studies. But to gain full approval, companies must eventually submit

Phase III data. In 2001, the FDA approved Gleevec for the treatment of

chronic myeloid leukemia based on preliminary Phase II data. Novartis

later gained full approval for Gleevec for CML and then received

approval to treat a rare type of gastrointestinal cancer.

Some patients have developed resistance to Gleevec and there's

currently no FDA-approved treatment for CML patients who are

Gleevec-resistant. So far, the studies of dasatinib suggest the drug

works in many of those patients.

Bristol-Myers said it is " likely treatment with dasatinib will result

in a survival benefit in patients, " based on the the Phase II data

which showed the drug produced a so-called cytogenetic response in

many patients.

The FDA typically follows its panel's advice, but isn't required to.

The agency is expected to make a final decision on dasatinib by the

end of the month.

The agency granted dasatinib priority review status, which the agency

grants to drugs or products that it believes are an advance over

existing treatments. It cuts about four months off of the typical

10-month FDA drug-review period.

In recent trading, Bristol-Myers shares were up 29 cents, or 1.2%, at

$24.84 on volume of 1.5 million. Average daily volume is 7.3 million.

-By Corbett Dooren, Dow Newswires; 202-862-9294;

.Corbett@...