Advexin gets rolling?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Introgen is requesting clearance for a rolling BLA submission for Advexin, the firm announces Dec. 23. Submission would begin immediately and complete before the end of 2005. Introgen is seeking accelerated approval for the orphan head and neck cancer therapy, which also has fast track status. Two Phase III studies are underway. Introgen recently released Phase II data in a sub-population of recurrent, unresectable head and neck cancer showing tumor growth control in 41% of patients, with an objective response rate of 15%. Median survival was 13.5 months for patiens with tumor growth control and 31.4 months for patients with objective responses...
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