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PFE....

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh65828_2006-01-26_20-15-42_n26...

UPDATE 1-US FDA approves Pfizer drug for two cancers

Thu Jan 26, 2006 03:15 PM ET
(Recasts with FDA approval)
By Ransdell Pierson and Lisa Richwine

NEW YORK/WASHINGTON, Jan 26 (Reuters) - Pfizer Inc. (PFE.N: Quote, Profile, Research) won U.S. approval for its drug Sutent for fighting two hard-to-treat cancers of the kidney and stomach, U.S. regulators said on Thursday.

The Food and Drug Administration said it cleared Sutent for treating patients with advanced kidney cancer or a rare stomach cancer known as GIST.

"Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult-to-treat forms of cancer," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Sutent, or sunitinib, is a once-daily capsule that blocks several enzymes known as kinases that allow cancer cells to multiply.

Earlier Thursday, researchers reported that Sutent slowed growth of stomach cancer and significantly prolonged the lives of patients who had developed resistance to Novartis AG's (NOVN.VX: Quote, Profile, Research) Gleevec pill.

"(Sutent) is the first molecularly targeted therapy proven to work against a cancer after another targeted therapy has failed," said Dr. George Demetri, the study's lead investigator.

Risk of death among stomach cancer patients taking Sutent was less than half that of patients in the trial taking placebos. And cancer among the average patient taking Sutent did not progress for 27.3 weeks, more than four times longer than the 6.4-week average for the placebo group.

All 312 patients enrolled in the trial had stomach cancer that had spread to other parts of the body or that could not be removed through surgery. Moreover, all patients had previously taken Gleevec, but no longer benefited from it.

Two-thirds of the participants received Sutent, while remaining patients took placebos.

Patients in cancer trials typically do not get just placebos because it is considered unethical to deny them effective treatments. But they received placebos in this trial because no standard drug is known to work against such stomach tumors once they develop resistance to Gleevec.

Demetri, associate professor at Harvard Medical School, said the study was highly significant because of the improved survival shown for Sutent. He presented the findings at the annual Gastrointestinal Cancers Symposium in San Francisco.

When it became clear that patients taking Sutent were surviving longer than the placebo group, all patients in the study were allowed to start taking the Pfizer drug. The trial is continuing.

Pfizer, which acquired Sutent in 2003 through its purchase of Pharmacia Corp., has said it intends to become a major player in the oncology arena. It is now far better known for drugs such as Viagra and cholesterol fighter Lipitor.