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Published on 17 December 2009

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FDA panel rejects OSI cancer drug

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A US Food and Drug Administration (FDA) panel has voted 12-1 against approving the lung-cancer treatment Tarceva for use in patients who have already undergone successful chemotherapy.

The share price of manufacturer OSI Pharmaceuticals fell by almost 7% after the decision was announced.

The drug was approved for patients whose cancer has spread despite chemotherapy after a company study showed it stopped cancer from progressing for three months.

OSI said that the new use would be “an important advance” in treating lung cancer, and “will work diligently to respond to the issues that arose as quickly as possible.”

The FDA had said it was unclear whether earlier use of Tarceva was any better than the current regime, in which patients begin taking the drug only after their cancer has returned.

The FDA is not required to follow the advice of its panels, though it usually does. A decision on Tarceva is expected by January 18.

Copyright Press Association 2009



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