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Published on 15 December 2009

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FDA considers benefits of Tarceva

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The lung-cancer drug Tarceva slows the progression of the disease when used as a follow-up to chemotherapy, according to the US Food and Drug Administration (FDA).

Manufacturer OSI Pharmaceutical is seeking approval for its use as a maintenance therapy, adding to secondary treatment clearance for patients in whom cancer has progressed after chemotherapy.

Company trials have shown that Tarceva stops cancer from progressing for about three months when taken immediately after chemotherapy.

But the FDA is concerned about other available treatments, and is to ask a panel of outside experts to compare Tarceva with the Sanofi Aventis chemotherapy drug Taxotere as a secondary therapy.

The FDA accepts that Tarceva and Taxotere both extend lives, but is considering whether Tarceva as a maintenance therapy is better than using it or Taxotere only after initial chemotherapy has stopped working.

Copyright Press Association 2009



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