An FDA approval for Tykerb may be in the offing

A host of analysts are predicting that GlaxoSmithKline will win FDA approval for its breast cancer drug Tykerb this week. One analyst pegged its potential at $1.16 billion a year by 2012. Tykerb has a clear advantage over the blockbuster Herceptin because it is administered in pill form while Herceptin is injected. And data supports that Tykerb in combination with Xeloda is more effective that a treatment consisting only of Xeloda.

If the approval does come through, it will be a notable win for Glaxo, which is working hard to find replacements for other therapies that are losing revenue. It will also be a signal validation for the researchers who continued to champion Tykerb even as the company considered dropping the program. Glaxo changed the drug development process to give scientists more authority over which drugs to develop.

- read the Wall Street Journal article on Tykerb (sub. req.)

ALSO: An approval will lead to 150 new jobs in Ireland as Glaxo gears up production. Report

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