EMEA accepts MAA for Introgen's Advexin

The European Medicines Agency (EMEA) has accepted for review the Marketing Authorization Application for Advexin, a first-in-class p53 tumor suppressor therapy developed by USA-based Introgen, for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck. If approved, it will be the first gene therapy product approved for use in Europe.

The MAA is based upon a clinical data package which includes results from Introgen's open-label, multicenter, randomized, comparative Phase III study of Advexin in patients with recurrent, refractory SCCHN.

This pivotal trial successfully achieved both the study's primary and secondary efficacy endpoints in the p53 biomarker patient population, which were each prospectively designated. The primary efficacy endpoint was survival in either the intent-to-treat or biomarker patient population. The secondary endpoint was tumor response in either group.