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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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... ots.at: Lilly Launches Phase III Trial of Targeted Cancer Agent text.ots.atmobile.ots.at presseportal.at tourismuspresse.at euroadhoc.com politikportal.at ---- presseportal.de presseportal.ch Home < Wirtschaft < Volltext Kontakt Impressum Profisuche Hilfe E-Mail Passwort Login Erstanmeldung Hilfe Für AOM-User Ohne AOM-Account Hilfe Produkte & Preise Eli Lilly and Company / 09.03.2006 / 12:06 / OTE0008 5 WA 0818 PRN0010 Lilly Launches Phase III Trial of Targeted Cancer AgentIndianapolis (ots/PRNewswire) - - Enzastaurin Study Enrolling Patients with Glioblastoma One of the deadliest and rarest forms of cancer is the focus of a Phase III study initiated by Eli Lilly and Company today.

Enzastaurin, an investigational, targeted, oral agent, will be evaluated at more than 100 sites worldwide for the treatment of relapsed glioblastoma multiforme (GBM), an aggressive and malignant form of brain cancer.

"Glioblastoma is a devastating disease for patients often slowly impacting their cognitive thinking and emotional responses," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Eli Lilly and Company.

"Through its distinct mechanism of action, preclinical studies suggest that enzastaurin attacks the tumor in multiple ways.

While there have been some recent advances in treating this devastating disease, survival rates are still low.

Enzastaurin is a promising agent, and we look forward ...