Most CML patients on Gleevec alive after 5 years

June 4, 2006

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Most CML patients on Gleevec alive after 5 years

Sat Jun 3, 2006 3:03 PM ET

ATLANTA, June 3 (Reuters) - Nearly 90 percent of patients with chronic

myelogenous leukemia who were treated with Novartis AG's <NOVN.VX> Gleevec

were alive after five years, new data shows, compared to the no more than 50

percent survival rate with other therapies.

Data presented on Saturday at the annual meeting of the American Society of

Clinical Oncology in Atlanta showed that at five years, the overall survival

of 553 patients who received Gleevec as their initial therapy was 89

percent.

" This trend, if it holds, coupled with the low risk of relapse, means that

the possibility of long-term survival with CML is increasingly likely, " said

Dr. Druker, who helped develop Gleevec and is a chair of leukemia

research in the Oregon Health & Science University Cancer Institute.

The typical rate of survival of patients who took other therapies was no

more than 50 percent, investigators said.

The trial was begun in 2000 and involved 1,106 subjects. Half received

Gleevec and half received standard treatment at the time the trial started

-- interferon-alpha and cytarabine arabinoside. Participants were allowed to

cross over to the Gleevec group and only 3 percent remain on interferon.

Gleevec was approved in 2001 by the U.S. Food and Drug Administration. In

2002 it was approved for gastrointestinal stromal tumors (GIST), a rare form

of abdominal cancer, in 2002.

About 4,600 new CML cases are diagnosed each year in the United States,

according to The Leukemia & Lymphoma Society.

On Friday, an FDA advisory panel recommended the agency approve an

experimental Bristol-Myers Squibb Co. <BMY.N> pill for patients who had

failed other treatments.

The drug, Sprycel, reduced or eliminated leukemia cells in some patients who

had stopped responding to Gleevec or could not tolerate it.

So far it is unknown how long the effects last or whether patients live

longer, FDA reviewers said.

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