GSK’s Tykerb gets priority review
The designation means a decision on Glaxo’s application must come within six months of the drug’s filing date with the FDA, which was Sept. 18.
Glaxo is seeking to market Tykerb as a treatment to be used in combination with Roche’s Xeloda for breast cancer that has spread to other parts of the body. Tykerb, if approved, would compete with Roche and Genentech’s rival drug Herceptin.
Analysts predict that Tykerb be a $4 billion-a-year seller, depending on how it performs against Herceptin.