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FDA Panel Approves OSI Pharmaceuticals' Anti-Cancer Drug Tarceva

Posted on: Friday, 16 September 2005, 21:00 CDT

OSI Pharmaceuticals got some good news late Tuesday when an advisory panel to the U.S. Food and Drug Administration voted to approve anti-cancer drug Tarceva to treat advanced pancreatic cancer.

The FDA's Oncologic Drug Advisory Committee voted 10-to-3 in favor of recommending approval of Tarceva to be used along with anti- cancer drug gemcitabine for advanced pancreatic cancer.

OSI said the FDA is expected to review the recommendation and decide whether to approve Tarceva by Nov. 2.

Tarceva is the first drug in a Phase III trial to have shown a significant improvement in overall survival when used with gemcitabine chemotherapy in advanced pancreatic cancer, according to OSI.

Tarceva is already approved to treat non-small cell lung cancer following chemotherapy.


Source: Long Island Business News

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