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U.S. approves drug for ovarian cancer, spurns panel
NEW YORK, - The U.S. Food and Drug Administration approved the drug Gemzar for treating recurrent ovarian cancer, ignoring the advice given by an FDA panel earlier this year that had strongly recommended against approval, Eli Lilly and Co., the drug maker, said Monday.
The FDA approved use of Gemzar in combination with carboplatin, a widely used chemotherapy, for women with advanced ovarian cancer that has relapsed at least six months after initial therapy. Although the FDA usually follows the advice of its advisory panel, Lilly spokesman Gregory Clarke said that the FDA approved Gemza, also know by its generic name gemcitabine, for ovarian cancer after the company provided the agency with additional information.
About 22,000 American women are diagnosed with the disease and about 16,000 die from it each year, according to the American Cancer Society. In most women tumors tend to recur, making treatment difficult and resulting in low survival rates.
Gemzar is already approved in the United States for lung, pancreatic and breast cancers and is approved outside the United States for ovarian cancer.
In a late-stage clinical trial, ovarian cancer patients taking Gemzar plus carboplatin had significantly longer progression-free survival than patients taking carboplatin alone, according to the Indianapolis-based Lilly.
In March, the FDA advisory panel voted 9-2 against recommending approval of Gemzar for ovarian cancer, questioning Lilly's trial data and the way the company conducted the 356-person clinical study. Panel members were concerned that patients in the trial did not survive longer than those taking carboplatin alone.
The company said their goal for the drug was to prevent the cancer from worsening, not to help patients live longer.
"This is a situation where we were able to provide the FDA with additional analysis of the data that may have given a little more insight on the benefits" of Gemzar, Clarke said.
FDA officials could not be reached immediately for comment.
Clarke said this is the first time the FDA has approved a drug for ovarian cancer based upon progression-free survival, rather than an outright survival benefit.
One course of treatment with Gemzar costs about $12,600, he said.
Although women with recurrent ovarian cancer don't live longer on Gemzar, Clarke said the drug allows them to have less frequent chemotherapy -- sparing them the some side effects of these drugs.
Lilly, meanwhile, is testing other drugs against ovarian cancer to see if they can prolong survival, Clarke said.
(Additional reporting by Julie Steenhuysen in Chicago and Susan Heavey in Washington)
