FDA Waiting For EGFR Diagnostic Kit Data As Supplement To Vectibix BLA
Executive Summary
In what could signal a trend for targeted therapies, FDA concluded in its review of Amgen's epidermal growth factor receptor inhibitor Vectibix that the diagnostic test kit used to screen subjects for EGFR expression would need to be submitted as a supplement to the BLA
You may also be interested in...
FDA Offers Possible Reasons For Vectibix Failure To Show Survival Benefit
FDA review documents for Amgen's Vectibix (panitumumab) outline possible factors that may have lead to the epidermal growth factor receptor inhibitor's failure to show an overall survival benefit in a pivotal trial, including the possibility that the trial was not powered to show a modest effect
Asia Spotlight: Ascendancy Healthcare CEO Sandy Zweifach On The Gap In China
Seeing a gap between the large infrastructure being built in China by multinational and domestic companies, Ascendancy hopes to be an interface to help China access drugs from the West.