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... News US Advisers Against New Indication for Gemzar By Susan Heavey GAITHERSBURG, Md.

MAR 14, 2006 (Reuters) - Advisers to the U.S.

Food and Drug Administration recommended on Monday against approving Eli Lilly & Co.'s Gemzar (gemcitabine/paclitaxel) to treat relapsing ovarian cancer, saying stabilizing the disease without boosting overall survival was not enough to win their support.

The advisory panel voted 9-2 against approval, questioning the data Lilly provided to back the new use of Gemzar, which is already cleared in the United States to treat lung, pancreatic and breast cancers.

One panelist abstained.

The FDA will make the final decision, but usually follows the advice of its advisory panels.

Lilly is seeking to market Gemzar for relapsed cases of advanced ovarian cancer when used with carboplatin.

While company officials said the drug's goal was to prevent the cancer from worsening, not to help patients live longer overall, most panel members said they were not convinced that the goal was worth their support.

"I can't get over the fact that there is no survival benefit," said the panel's patient advocate, Martha Solonche of New York.

Several panelists also said the bid was premature and criticized the way the company conducted its 356-person clinical trial.

"I think this is a relatively poorly designed study," said Dr.

Stacy Nerenstone, an associate professor at the University of Connecticut.

"I just don't think the data is there to give that k...

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